RAPS RAC Exam 2026

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT:

A. The dates and results of the investigation

B. The nature and details of the complaint

C. Changes in procedures correcting quality problems

D. Any reply to the complainant

C. Changes in procedures correcting quality problems

The requirement is for corrective and preventative action and only needed if a corrective action was taken as a result of the investigation. See Sec. 820.198. Complaint Files.

A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should:

A. Write a letter to FDA requesting a Type A meeting as an amendment to the IND

B. Request a Type B meeting as an amendment to the IND

C. Call the project manager and set up a date over the phone for a Type C meeting

D. Email the division director with a list of three dates, 30 days into the future

B. Request a Type B meeting as an amendment to the IND

See the CDER/CBER guidance published in February 2000 entitled Formal Meetings With Sponsors and Applicants for PDUFA Products.

Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938 passage of

A. The Pure Food and Drug Act

B. The Federal Food Drug and Cosmetic Act

C. The Kefauver-Harris Drug Amendments

D. The Public Health Service Act

B. The Federal Food Drug and Cosmetic Act

What products are exempt from the Prescription Drug User Fees Act (PDUFA)?

A. Generic drugs only

B. Orphan drugs and cosmetics only

C. OTC drugs, cosmetics, generic drugs and medical devices

D. Prescription drugs marketed before 1992

C. OTC drugs, cosmetics, generic drugs and medical devices

MDUFMA is an acronym for:

A. Managing Department for the Unification of Foreign Medicinal Applications

B. Medical Device Users Fee and Modernization Act

C. Modernization of Devices Used for Medical Anomalies

D. Medical Device Universal Fees for Marketing Applications

B. Medical Device Users Fee and Modernization Act

Which is not a division of the FDA?

A. CDRH

B. CDER

C. CFER

D. CVM

C. CFER

What is the mission of the FDA?

A. Promote public health

B. Protect public health

C. Pursue international harmonization

D. All of the above

D. All of the above

The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated records:

True or False

FALSE

Veterinary drugs are regulated under the Center for Drug Evaluation and Research (CDER), because the requirements for approval are the same:

True or False

FALSE

Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?

A) Safe Medical Devices Act of 1990 (SMDA)

B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

C) Federal Food, Drug, Cosmetic Act (FDC Act)

D) Medical Device Amendments of 1976 (MDA)

D) Medical Device Amendments of 1976 (MDA)

In order of highest level to lowest level, the ranking at US governmental organizations is:

A. Division, Office, Center, Agency, Department

B. Department, Agency, Center, Office, Division

C. Center, Department, Division, Agency, Office

D. Agency, Center, Office, Department, Division

B. Department, Agency, Center, Office, Division

Your company is developing a new drug to be developed and used in combination with a cystoscopic light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is:

A. Submit a Request for Designation to FDA Office of Combination Products for determination of the lead center for primary jurisdiction for the combination product

B.Make a preliminary internal company determination of the combination product's primary mode of action

C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug Products (OODP)

D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products

B.Make a preliminary internal company determination of the combination product's primary mode of action

For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at which of the following intervals?

A. 1 month

B. quarterly

C. at completion

D. periodically

D. periodically

Audits should be conducted at intervals appropriate to assure the integrity of the study (rules out answers A,B and C).

Periodic auditing by the quality assurance unit is required as appropriate for the study (21CFR58.35(b)(3)

Good Laboratory Practices Regulations govern the:

A. Conduct and control of laboratory activities

B. Conduct of nonclinical laboratory studies

C. Determination of product efficacy in animals

D. Determination of product feasibility

B. Conduct of nonclinical laboratory studies

A. The regulation does not cover physical or chemical testing

B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to determine safety

C. Testing to determine utility is excluded

D. Basic exploratory studies are excluded

Consent from subjects for clinical study enrollment is a:

A. Proposed rule

B. Final rule

C. Recommendation

D. Guideline

B. Final rule

The FDA regulation on informed consent became a final rule on 27 January 1981 (21 CFR 50)

All of the following are requirements of an IRB, EXCEPT

A. Has at least 5 members

B. Includes at least 1 nonscientific member

C. Obtains informed consent from all subjects

D. Represents the cultural mix of the community

C. Obtains informed consent from all subjects

A. It is a requirement that each IRB have at least 5 members (21 CFR56.107(a)

B. The regulations require each IRB to have at least 1 member whose primary concerns are in the scientific area and at least 1 whose primary concerns are in nonscientific areas ((21 CFR56.107(c)

C. It is the responsibility of the clinical investigator to obtain consent from all subjects, not the IRB (21 CFR 312.60)

D. The regulations require each IRB to have a diversity of members (race, gender, cultural backgrounds ) (21 CFR56.107(a)

Financial Disclosure is required for investigators who, during the time the clinical investigator is carrying out the study and for one year following the completion of the study, have:

A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD

B. Been paid $15,000 USD for conducting clinical trials with the sponsor

C. A spouse who has been paid as a consultant by the company before the study began

D. Is not a requirement for Phase 2 studies

A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD

Phase 2 clinical trials are being planned for a novel cancer drug. All the following are appropriate factors in the phase of the study EXCEPT?

A. Enrollment of cancer patients

B. Enrollment of healthy subjects

C. Study of one or more indications

D. Collection of efficacy data

C. Study of one or more indications

Sponsors of a clinical trial must immediately notify FDA and investigators of SAEs EXCEPT?

A. Temporally associated with the use of the investigational item but are not serious and/or unexpected

B. Described in the IB but with greater severity

C. Life-threatening or result in inpatient hospitalization

D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the drug

A. Temporally associated with the use of the investigational item but are not serious and/or unexpected

From a subsidiary in Ireland, you are forwarded a report that a patient taking your drug was hospitalized with a case of Stevens-Johnson syndrome. This hypersensitivity reaction is not listed on your label. You should report this case to FDA:

A. Within 15 calendar days of receipt

B. Within 15 business days of receipt

C. Within 10 business days of receipt

D. With the next periodic adverse drug experience report

A. Within 15 calendar days of receipt

Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System?

A. Production and process controls

B. Test and control article characterization

C. Packaging and labeling controls

D. Facility and equipment controls

B. Test and control article characterization

This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not by quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals are required by 21CFR 211, Subpart I.

In order to ensure that a facility complies with GMP requirements, all of the following features should be evaluated EXCEPT:

A. Air handling system

B. Animal supply facilities

C. Lighting

D. Potable water

B. Animal supply facilities

Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR 58.45.

According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the:

A. Device history record

B. Device master record

C. Quality manual

D. Design history file

A. Device history record

This contains the dates of manufacture, the quantity manufactured, the quantity released for distribution, control numbers used and the acceptance records which demonstrate the device is manufactured in accordance with the DMR. See 21 CFR 820.184.

In the development of a revised manufacturing procedure, which of the following is a critical step in ensuring that the product manufactured would not be adversely affected by the change?

A. Procedure qualification

B. Product verification and/or process validation

C. Quality control

D. Conformance inspection

B. Product verification and/or process validation

This ensures that the product has not been adversely affected.

A company's supplier of the active drug substance for the company's OTC monograph drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA?

A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change.

B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location.

C. The change does not have to be reported because it is an OTC monograph drug.

D. An amendment to the OTC monograph should be filed.

C. The change does not have to be reported because it is an OTC monograph drug.

As this is an OTC monograph product there would be no FDA administrative file to report the change to.

For which of the following records is 21 CFR Part 11 NOT applicable?

A. Records in electronic format in lieu of paper format which are required to be maintained under predicate rule

B. Records in electronic format in lieu of paper format which are not required to be maintained under predicate rule

C. Records in electronic format in addition to paper format which are required to be maintained under predicate rule

D. Electronic records that are intended to be the equivalent of handwritten signatures required by predicate rules

B. Records in electronic format in lieu of paper format which are not required to be maintained under predicate rule

Part 11 is not applicable to electronic records not required under predicate rules as per FDA Final Guidance August 2003.

GMP is required for both commercial and clinical materials including Phase 1

True or False

TRUE

The following are characteristics of FDA GMP inspections EXCEPT:

A) Results of internal audit findings are required to be provided to the FDA Inspectors upon request

B) Biennial inspections of manufacturing facilities take place to verify compliance with regulations.

C) The FDA may inspect the drug product sponsor and any manufacturing subcontractors.

D) FDA inspections may be conducted due to serious non-compliance with GMP regulations

A) Results of internal audit findings are required to be provided to the FDA Inspectors upon request

FDA can request SOPs and other supporting information to confirm a process for conducting internal audits. Actual written audit reports are not shared with FDA during an inspection. Actual written audit reports are not shared with FDA during an inspection.

According to GMP regulations, the quality control unit is responsible for which of the following activities:

A) Issuing unique identification to all major manufacturing equipment

B) Manufacturing drug products

C) Warehousing and distributing drug products

D) Approving and rejecting raw materials, components, label, drug products, procedures and specifications

D) Approving and rejecting raw materials, components, label, drug products, procedures and specifications

Management should be notified in writing of the GMP Investigations conducted for all of the following except:

A) Product Complaints

B) Batch Production Record documentation corrections

C) Returned Drug Products

D) Drug Product Salvaging

B) Batch Production Record documentation corrections

(least severe/critical)

According to GMPs, the following product labels should be rejected except which of the following:

A) Labeling and packaging materials that do not meet the approved specifications

B) Gang-printed labeling

C) Obsolete and outdated labels

D) Labeling and packaging materials stamped with the lot number remaining at the end of a production run

B) Gang-printed labeling

Gang printed labeling means labeling derived from printed material on which more than one item of labeling is printed - there are special controls on this type of label to avoid errors

D) Incorrect - should be rejected - lot finished, label cannot be re-used

After submission of an NDA, FDA will make decisions within X days if they will file the NDA.

A. 30 days

B. 60 days

C. 45 days

D. 6 months

B. 60 days

Which of the following products is required to carry National Drug Code (NDC) number?

A. every human prescription drug product

B. over the counter drug

C. animal drug product

D. any drug intended for human or animal use

D. any drug intended for human or animal use

Animal drugs also have NDC numbers, but the NDC Directory only lists human drugs.

As with a human drug, an NDC number on an animal drug's label does not mean the drug is FDA-approved.

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit:

A. Only the list of all active ingredients, antimicrobial preservatives and antioxidants, with their pharmaceutical grades and the names of the suppliers

B. Drug Master File authorization letters from each supplier of active ingredients, antimicrobial preservatives and antioxidants

C. GMP Certifications from the suppliers of all active ingredients and excipients

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

The term of a new patent is:

A. 20 years from date of NDA approval

B. 20 years from the date of filing for the patent

C. 14 years from date of NDA approval

D. 14 years from the date of filing for the patent

B. 20 years from the date of filing for the patent

Which one of the following is not true regarding the "Regulatory Review Period" for Patent term extension:

A. Regulatory review period is composed of "testing phase" and "review phase"

B. Sum of half of the time of the testing phase + all the time in review phase

C. Begins on the effective date of an IND and end on the date of submission of NDA

D. The total calculated regulatory review period may not exceed 5 years and extended patent term may not exceed 14 years.

C. Begins on the effective date of an IND and end on the date of submission of NDA

Begin on submission of NDA

Drugs approved through which one of the following applications will be included in the Orange Book as the "listed drug":

A. 505(b)(1) NDA

B. 505(b)(2) Application

C. ANDA

D. All of the above

D. All of the above

Which one of the following certifications are submitted if and ANDA applicant wants to challenge an Orange Book-listed patent by claiming that the patent is "invalid or will not be infringed by the manufacture, use....."

A. Paragraph I

B. Paragraph II

C. Paragraph III

D. Paragraph IV

D. Paragraph IV

If an NDA holder sues a ANDA applicant that submits Paragraph IV certification, the ANDA application delays for:

A. 30 days

B. 30 months

C. 45 days

D. 60 days

B. 30 months

5 -year exclusivity is given to which of the following applications:

A. Orphan drug

B. Pediatric

C. New Chemical Entity (NCE)

D. Patent Challenge (PC)

C. New Chemical Entity (NCE)

Which one of the following is referred to as "new clinical investigation" or "new use" exclusivity:

A. 5 year exclusivity

B. 3 year exclusivity

C. Pediatric exclusivity

D. Orphan exclusivity

B. 3 year exclusivity

Which statement is true about over the counter (OTC) drugs?

A. They are regulated by the Division of Over the Counter Drugs

B. A prescription to over the counter switch is automatic after 3 years of sufficient marketing experience if no serious or life threatening events were reported to FDA

C. For most OTC drugs, an initial NDA was submitted for their use (they were not sold as prescription)

D. Additional clinical studies may be required to justify OTC use and safety of use without the intervention of a physician

D. Additional clinical studies may be required to justify OTC use and safety of use without the intervention of a physician

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA?

A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specification won't change

B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location

C. The change does not have to be reported because it is an OTC drug

D. Not enough information

D. Not enough information

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than:

A. 5 calendar days.

B. 15 calendar days

C. 30 calendar days.

D. The next quarterly or annual report.

C. 30 calendar days.

C. Serious injury must be reported within 30 days. 21 CFR 803.50(a).

MDUFMA authorized 3rd party establishment inspections. All of the following are true about these inspections EXCEPT:

A. You need to market at least one device in the United States.

B. Participation is mandatory.

C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.

D. Establishments are not required to obtain clearance of a 3rd party in advance.

B. Participation is mandatory.

B. Per section 201 of MDUFMA, establishments "may" participate. (The Food and Drug Administration (FDA) announced the availability of the guidance entitled ''Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002.'' The Medical Device User Fee and Modernization Act of 2002 authorizes FDA to establish a voluntary inspection program under which manufacturers of class II or class III devices who meet certain eligibility criteria as defined by the statute can elect to have FDA-accredited third parties conduct some of their establishment inspections instead of FDA. Per section 201 of MDUFMA, establishments "may" select an accredited person they are not "required" to do so.

The initial importer of a medical device MUST:

A. Register and submit device list to FDA.

B. Maintain quality assurance files.

C. Share responsibility for submittals with other distributors.

D. Report device malfunctions in an annual report.

A. Register and submit device list to FDA.

A. Distributors must list all initially imported devices with the FDA and establish themselves as device importers. 21 CFR 807.20(c).

Under the statutory violations, failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be:

A. Adulteration.

B. Improper use

C. Misbranded

D. Fraudulent

C. Misbranded

A marketed device that needs a 510(k) for commercialization but failed to comply with the requirements is considered to be Misbranded. See the FD&C Act, 502(o).

A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. When can the company's new suture be marketed?

A. This requires a new 510(k) since significant change in product instructions might affect efficacy.

B. After submission in a periodic report

C. After reporting clinical studies in an annual report

D. After submission of labeling change

A. This requires a new 510(k) since significant change in product instructions might affect efficacy.

A new intended use requires a 510(k) clearance.

You have modified your 510(k) cleared device with a special 510(k). In which of the following cases would you need to create a new listing for the device?

A. You have added new sizes and shapes in the product portfolio.

B. You have changed the material composition of the device.

C. You have changed the package of the device.

D. None of the above.

D. None of the above.

According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for each device or device class listed with the FDA. Devices having variations in physical characteristics such as size, package, shape, color or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT:

A. Conduct quality audits by individuals who do not have direct responsibility for the operation being audited

B. Audit operations annually

C. Document the dates and results of quality audits and re-audits

D. Have findings reviewed by management responsible for the matters audited

B. Audit operations annually

Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to determine that quality system activities comply with quality system procedures that these procedures are implemented effectively and that procedures are suitable to achieve quality system objectives.

A manufacturer which of the following must file an IDE before conducting a human clinical study?

A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time

B. A device intended solely for veterinary use

C. A custom device being studied for safety and effectiveness in support of commercial marketing

D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time and intended solely for veterinary use

C. A custom device being studied for safety and effectiveness in support of commercial marketing

While a custom device may be studied in humans without an IDE, if its safety and efficacy are being studied in support of commercial marketing, an IDE must be filed; see 21 CFR 812.2(c)(7).

MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following prescribed conditions about 3rd party establishment inspections are true EXCEPT:

A. The establishment must market at least one device in the US and must market a device "in one or more foreign countries."

B. Manufactures of class III devices are not eligible for 3rd party inspections.

C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.

D. Establishments are required to notify FDA of the person it intends to use and FDA must agree to the selection.

B. Manufactures of class III devices are not eligible for 3rd party inspections.

MDUFMA amends section 704 of the FD&C Act to authorize FDA accredited

individuals to inspect qualified manufacturers of class II and class III medical devices.

The Quality System Regulation includes requirements for Design Controls. All of the following statements about Design Reviews are true EXCEPT:

A. Manufacturers are required to maintain procedures to ensure that formal reviews occur at appropriate stages of a device's design and development.

B. Participation at design reviews must include representatives of all functions concerned with the stage being reviewed.

C. Participation shall include at least one individual who does not have direct responsibility for the stage being reviewed.

D. Results of the design review shall be documented in the device history record.

D. Results of the design review shall be documented in the device history record.

The results of the design review shall be documented in the device history file (DHF); see 21 CFR 820.30(e).

A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best filed as a(n):

A. Special 510(k)

B. Abbreviated 510(k)

C. Traditional 510(k)

D. PMA

B. Abbreviated 510(k)

If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the following typically occurs?

A. The labeling is revised

B. The product is recalled

C. The product is redesigned

D. A "Dear Doctor" letter is issued

A. The labeling is revised

The labeling should provide appropriate information for proper use of the product.

Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT:

A. A deviation from the investigational plan

B. Withdrawal of IRB approval

C. An unanticipated adverse device effect

D. Use of a device without informed consent

C. An unanticipated adverse device effect

Regulations

An investigator shall notify the sponsor and IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred.

If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs.

Withdrawal of IRB Approval

A sponsor shall notify FDA and all reviewing IRB's /investigators of any withdrawal of IRB approval within 5 working days after receipt of the withdrawal of approval.

An investigator shall report to the sponsor, within 5 working days, a withdrawal of IRB approval

An investigator shall submit to the sponsor and IRB a report of any unanticipated adverse device effect occurring as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.

Which of the following is exempt from GMP/QSR regulations?

A. Remanufacturers

B. Custom device manufacturers

C. Repackagers

D. Component manufacturers

D. Component manufacturers

Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).

All of the following are considered General Controls under the Food, Drug & Cosmetic Act EXCEPT:

A. Establishment registration

B. Premarket approval application

C. Medical device reporting

D. Listing of the device

B. Premarket approval application

Premarket approval application (PMA) is not a general control.

According to the Quality System Regulation, suitable maintenance of equipment is necessary to ensure that manufacturing specifications are met. All of the following are requirements for the equipment EXCEPT:

A. A written maintenance schedule is required

B. Allowable tolerances are posted on or near the equipment

C. Maintenance must be performed at least annually

D. Inspections of equipment must be documented

C. Maintenance must be performed at least annually

QSR does not specify "annually":

Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.

Which of the following devices would be regulated by CBER?

A. Warming device

B. Blood pressure cuff

C. HIV diagnostic test kit

D. Capillary blood collection tube

C. HIV diagnostic test kit

After the departure of therapeutic biological products to CDER, CBER was left with the rest which essentially amounts to blood and related products, vaccines and gene therapy, some devices and diagnostic test kits.

In the test question, I tried to distract you by putting blood into several of the responses because when I hear blood, I think CBER. The key words are HIV (read blood related) and diagnostic test kit

Thus, C is the best answer

A) Incorrect - regulated by CDRH

B) Incorrect - regulated by CDRH

C) Correct - in vitro diagnostic

D) Incorrect - regulated by CDRH

For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment?

A) Report adverse events under the Medical Device Reporting regulation

B) Assisting FDA in communications with the foreign establishment,

C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and

D) Assisting FDA in scheduling inspections of the foreign establishment.

A) Report adverse events under the Medical Device Reporting regulation

Which Congressional Act provided Statutory Authority to FDA to regulate medical devices?

A) Safe Medical Devices Act of 1990 (SMDA)

B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

C) Federal Food, Drug, Cosmetic Act (FDC Act)

D) Medical Device Amendments of 1976 (MDA)

D) Medical Device Amendments of 1976 (MDA)

Which of the following is NOT a key Medical Device submission which directly leads to marketing permission from FDA?

A) 510(k), Pre-market Notification, Part 807

B) HDE, Humanitarian Device Exemption, Part 814

C) Premarket Approval (PMA), Part 814

D) IDE, Investigational Device Exemptions, Part 812

D) IDE, Investigational Device Exemptions, Part 812

Your IDE is a permission to ship product for clinical trial use only. It is the mechanism to have an EXEMPTION to meeting the pre-market notification or pre-market approval requirements, in order to perform your clinical trials. IDE are a part of the process for product registrations that require clinical trial data, but the IDE does not directly lead to marketing permission.

Remember from one of the early drug slides, Carol mentioned the IND application. An IND provides an exemption from premarketing approval requirements and allows you to legally ship drug to conduct the proposed clinical study.

In the device world, an IDE investigation provides data to be used in your 510K or PMA, and in the drug/biologic world, an IND serves the same purpose for an NDA or BLA.

At completion of review of a 510(k), FDA may take the following actions except:

A) Declare device substantially equivalent

B) Declare device not substantially equivalent

C) State a 510(k) is not required to market the device

D) Approve the device for market

D) Approve the device for market

510(k) is for clearance to market not an approval

From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical device development?

A) Animal use testing to validate the design of your device

B) Bench testing to verify that your design performs as designed

C) Biocompatibility/Toxicity testing

D) Functional/Safety/Performance testing

E) All of the above

E) All of the above

NOT a RAC test style question

Pre-clinical refers to any testing NOT performed in a human being.

With respect to a Non-Significant Risk device clinical trial, which of the following is NOT required before starting the trial?

A) Informed consent of trial participants

B) IRB approval of the trial

C) Financial disclosure by investigators

D) Submission of the trial protocol to FDA for approval

D) Submission of the trial protocol to FDA for approval

FDA approval not needed for NSR (Non-Significant Risk device)

For studies not conducted under an FDA-approved IDE, (that is, a non-significant risk IDE or an exempt study), the sponsor would need to identify the investigators and sub-investigators they considered covered by the rule in form 3454 and 3455. We expect that there will be at least one such person at each site.

The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following except:

A) 21 CFR 50 Protection of Human Subjects

B) 21 CFR 56 IRB

C) 21 CFR 807 Establishment Registration

D) 21 CFR 812 IDE Exemptions

C) 21 CFR 807 Establishment Registration

Part 812 - Only covering setting up Clinical Trial - Requirements for what happens during a trial will be covered later.

Part 50 - Mention Foreign Studies here. These regulations apply only to studies conducted in the USA.

FDA will accept foreign data for marketing submissions. March 2001 guidance reaffirmed for devices FDA will accept data provided 1983 version of Declaration of Helsinki or the laws/regulations of the country the study is being conducted in are followed (whichever is stricter). Foreign data - similar protocol, applicable populations, etc.

Part 54 - published Feb. 2, 1998. Submit information in marketing application

Purpose to identify and disclose financial interests/agreements of clinical investigators that may affect the integrity of the data

Part 56 - Purpose of IRB is to protect the rights and welfare of human subjects

A key component of a new device for which a PMA is being prepared is manufactured by a second company. Without revealing proprietary information to the finished product manufacturer, how can the component manufacturer make critical information available to FDA for review?

A. Submit a Device Master File (MAF)

B. File its own PMA

C. Supply the applicable sections of the finished device manufacturer's PMA directly to FDA

D. Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA's requirements

A. Submit a Device Master File (MAF)

- A pre-market approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information.

- Often the applicant needs to use another party's product (e.g., ingredient, subassembly, or accessory) or facility in the manufacture of the device. In order that a sound scientific evaluation may be made of the PMA, IDE, or other device submission, the review of data and other information related to the other party's product, facility, or manufacturing procedures is required.

- The other party, while willing to allow FDA's confidential review of this information, may not want the IDE, premarket notification [510(k)], or PMA applicant to have direct access to the information.

- To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, FDA established the device master file system.

- In addition, a master file may be considered when several applications may be submitted for different products which may use a common material or process, etc., such as the same sterilization method.

This guideline only applies to the master files (MAFs) submitted to the Center for Devices and Radiological Health (CDRH). Master files in support of other products regulated by FDA, even though they may contain information previously submitted in an MAF, are to be submitted to the appropriate FDA center(s). The content and the way the master file is used may vary among FDA centers.

Other master files submitted for review in support of documents filed with FDA are:

- Biologics Master Files supporting Notices of Claimed Investigational Exemption for a New Drug (INDs) for biologics and biologic licenses.

- Drug Master Files (DMFs) supporting Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).

- Food Master Files (FMFs) supporting Food Additive and Color Additive Petitions.

- Veterinary Medicine Master Files supporting Investigational New Animal Exemptions (INADs) and New Animal Drug Applications (NADAs).

Under the official definition of a "device", all of the following are considered devices except:

A) X-ray film

B) Sterilizers used for device manufacturing

C) Eyeglass lenses and frames

D) In vitro diagnostic kit

B) Sterilizers used for device manufacturing

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.

- Eyeglass frames, 886.5842

- Lenses, spectacle, 886.5844

-Sunglasses, non-prescription, 886.5850

510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except:

A) High Flux Hemodialyzer

B) Blood specimen collection device

C) Piston syringe

D) Cardiopulmonary bypass blood tubing

B) Blood specimen collection device

This is a recall question related to the proper Center and proper type of submission required for market clearance

The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following:

A) Finished devices, but not accessories

B) Finished devices and components of finished devices

C) Finished devices and accessories to finished devices

D) Finished devices, components, and accessories to finished devices

C) Finished devices and accessories to finished devices

The Quality System Regulation for Class III devices applies to the following except:

A) Critical component manufacturers

B) Operations done by the manufacturer at facilities located in the United States

C) Research on investigational devices tested outside of the United States

D) Contract Sterilizers

A) Critical component manufacturers

A "component" is defined by 21 CFR 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device."

The Quality System Regulation (QSR) for medical devices (21CFR 820) requires all of the following except:

A) Management to make a commitment to quality

B) A Quality Plan that defines how quality will be met

C) Management must review the Quality System at least quarterly

D) A Quality representative must be identified and documented

C) Management must review the Quality System at least quarterly

Remember, I said that the QSR is written in a "generic" voice where what you are expected to do is stated but HOW you accomplish the requirement is not detailed.

The Quality System Regulation (QSR) for medical devices regarding Design Controls require which of the following:

A) Documentation of early research of the design

B) Design and development plans address how design inputs and requirements are managed

C) A product design can be outsourced by a manufacturer so they do not have to maintain the documentation

D) Design activities are only required for Class III Investigational devices

B) Design and development plans address how design inputs and requirements are managed

Design Control "verification" requires which of the following:

A) The product design meets the users needs

B) The process produces a product that meets predetermined specifications

C) The product design meets specified requirements

D) The product design meets the intended use requirements

C) The product design meets specified requirements

According to the QSR, Design Inputs are best described by the following:

A) The Operator's Manual and instructions on how to use the device

B) The Instructions For Use (IFU) of the device

C) Marketing claims and features that are required for the device

D) The performance requirements that the product must meet

D) The performance requirements that the product must meet

According to the QSR, Design Outputs contain the following:

A) The Device Master Record (DMR)

B) The documentation from the last phase of the complete Design Control process

C) The test reports that support that the Design Inputs have been met

D) All of the packaging and labeling associated with the finished device

E) A and D above

E) A and D above

NOT RAC TEST STYLE QUESTION

Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record

According to the QSR, Quality Audits must accomplish the following:

A) Meet the same requirements of the original GMP

B) Evaluate if the Quality System is in compliance with the QSR

C) Determine the effectiveness of the Quality System

D) Focus on Design Controls and the CAPA system

E) B and C above

F) A and D above

E) B and C above

B) Evaluate if the Quality System is in compliance with the QSR

C) Determine the effectiveness of the

Each manufacturer shall establish procedure for quality audits and conduct such audits to assure that the QS is in compliance with the established QS requirements and to determine the effectiveness of the QS.

Quality System

FDA investigators may review the schedule for your internal audits but are not supposed to ask to see the audit results

From the QSIT Manual:

Review the firm's quality audit schedules to assure quality audits are being conducted with sufficient frequency. It is recommended that the time between quality audits not exceed a 12-month period. More frequent audits may be recommended if the firm has a serious Quality System Regulation problem. Evidence of inadequate auditing may exist without gaining access to the written quality audit reports.

According to the QSR, personnel involved in the design, manufacture, distribution, servicing, and reporting must:

A) Must hold a Master's degree or higher

B) At a minimum receive procedure training once per year in their area of responsibility

C) Be able to recite the Quality Policy, if asked

D) Be made aware of defects which may occur if they do not perform their job correctly

D) Be made aware of defects which may occur if they do not perform their job correctly

According to the QSR, Document Controls apply to:

A) Design History File (DHF)

B) Device Master Record (DMR)

C) Device History Record (DHR)

D) All of the above

D) All of the above

(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device

(i) Device history record (DHR) means a compilation of records containing the production history of a finished device

(j) Device master record (DMR) means a compilation of records containing the procedure and specifications for a finished device

If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, what is the statutory violation?

A) Adulteration

B) Improper Use

C) Misbranding

D) Idiocy

A) Adulteration

Pre-market Notification Requirements would apply to a device that is:

A) Substantially equivalent to a pre-amendment device

B) Intended solely for use by a specific physician

C) Not equivalent to currently marketed devices

D) Intended for veterinary use

A) Substantially equivalent to a pre-amendment device

Premarket Notification Requirements apply to:

-New medical devices that are not:

1. Exempt (most Class I and some Class II)

2. Custom devices (FD&C Act § 520(b) and 21CFR 812.3(b))

3. Subject to PMA requirements (most Class III)

-Medical devices already cleared by FDA if:

1. New intended use

2. Significant modifications in design, materials/composition, specifications, labeling

3. New "sponsor" who has not legally acquired rights to the original 510(k)

You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the devices your firm sterilizes that are commercially available in the U.S. Which of the following responses is correct?

A) Contact FDA to request a large number of Device Listing forms and assign a member of your staff to begin completing a form for each device your firm sterilizes.

B) Exclude devices from foreign manufacturers from the list being prepared above.

C) Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

C) Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

The MDR regulations require that which of the following groups are not required to notify FDA if they become aware of information required to be reported.

A) Manufacturers

B) Distributors

C) Initial importers

D) User facilities

B) Distributors

Distributors are not required to report to FDA

Which of the following conditions may be expected to lead to a field recall action?

A) Market Withdrawal for correction or removal of distributed devices involving no violation or minor violation of Federal Food, Drug & Cosmetic Act

B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection

C) Stock Recovery of a device has not left direct control of manufacturer

D) Routine servicing

B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection

Market Withdrawal

Correction or removal of distributed devices involving minor violation or no violation (i.e., normal stock rotation)

Removal

Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection

Stock Recovery

Device has not been marketed or has not left direct control of manufacturer

Routine servicing (meaning regularly scheduled) does not include unexpected repairs or identical replacements of multiple units

An OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks is an example of what type of device?

A) Class 1

B) Class 2

C) Class 3

D) Not a device

B) Class 2

Special controls are FDA's "Use of International Standard ISO 10993 'Biological Evaluation of Medical Devices...' and "OTC denture reliners, repair kits, partially fabricated denture kits

Sec. 872.3570 OTC denture repair kit.

- Identification. An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter.

- Classification. Class II. The special controls for this device are FDA's:

- "Use of International Standard ISO 10993 `Biological Evaluation of Medical Devices--Part I: Evaluation and Testing,' " and

- "OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits." [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000]

An liquid-filled teething ring (for use by infants) is an example of what type of device?

A) Class 1

B) Class 2

C) Class 3

D) Not a device

B) Class 2

Class 2 (Exempt from pre-market notification procedure)

Class 1 if not liquid filled

Sec. 872.5550 Teething ring.

- Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.

- Classification.

- Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

- Class II if the teething ring contains a fluid, such as water. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

Dental floss is an example of what kind of device?

A) Class 1

B) Class 2

C) Class 3

D) Not a device

A) Class 1

Class 1 (Exempt from pre-market notification procedure)

Sec. 872.6390 Dental floss.

- Identification. Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.

- Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 872.9.

An acupuncture needle is an example of what kind of device?

A) Class 1

B) Class 2

C) Class 3

D) Not a device

B) Class 2

Special controls:

Label for single use only

conformance to requirements for prescription devices

Device material biocompatibility

Device sterility

Sec. 880.5580 Acupuncture needle.

- Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

- Classification. Class II (special controls).

- Acupuncture needles must comply with the following special controls:

- Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,

- Device material biocompatibility,

- Device sterility.

A non-powered microsurgical instrument for use in neurological microsurgery procedures is an example of what kind of device?

A) Class 1

B) Class 2

C) Class 3

D) Not a device

A) Class 1

Class 1, exempt from premarket notification

Sec. 882.4535 Nonpowered neurosurgical instrument.

- Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

- Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Non-prescription sunglasses are an example of what kind of device?

A) Class 1

B) Class 2

C) Class 3

D) No way is this a device

A) Class 1

Class 1, exempt from premarket notification

Sec. 886.5850 Sunglasses (nonprescription).

- Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

- Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

A male condom is an example of what class of device?

A) Class 1

B) Class 2

C) Class 3

D) Not a device

B) Class 2

Meet performance standards

Same class if condom has or does not have spermicidal lubricant, different CFR reference

Sec. 884.5300 Condom.

- Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of venereal disease). The device may also be used to collect semen to aid in the diagnosis of infertility.

- Classification. Class II (performance standards).

Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption?

A) Special PMA Supplements/CBE

B) PMA Manufacturing Site Change Supplements

C) Real Time Supplement

D) 30 Day Notices 135 Day Supplements

C) Real Time Supplement

An important distinction of a Humanitarian Use Device (HUD) according to the Humanitarian Device Exemption (HDE) is that:

A) The HDE application must contain the same i,

B) An HDE application is not required to conta

C) An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose.

D) An HDE application must be within 30 days a

C) An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose.

Regulatory Reference: 21 CFR Part 814 (Subpart H)

A new Class II device with electrical components was subjected to extensive standard testing such as the International Electrotechnical Commission (IEC) series (recognized conformance standard). The tests were conducted by a third party. Which route of submission is the most suitable for this device?

A Traditional 510k

B Special 510k

C Abbreviated 510k

D PMA

C Abbreviated 510k

A manufacturer has the option to submit an Abbreviated 510(k) when FDA has recognized relevant consensus standards that are applicable to the device. This Abbreviated 510(k) will include a declaration of conformity to the recognized consensus standards, and this declaration, in many cases, should eliminate the need to review actual test data for those aspects of the device addressed by the standards, thus the review will be more efficient. Regulatory Reference: FD&C Act Section 514 ; The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications—Final Guidance ; Guidance for Industry and FDA Staff: Recognition and Use of Consensus Standards ; FDA Standards Database Search (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm) ; 21 CFR Part 814.

In a medical device company, which of the following units has ultimate responsibility for the integrity of the data and the quality of the product:

A Quality Assurance

B Quality Control

C Management

D Regulatory Compliance

C Management

Management has the ultimate responsibility to ensure that the quality systems are effective and a quality policy is implemented and followed as intended, which assures the integrity of the data and quality of the product. Regulatory Reference: 21 CFR 820.20(a).

When should the manufacturer of a Class III medical device expect to have an FDA establishment registration inspection?

A) Following submission of an IDE application

B) After Phase II of the IDE study

C) Prior to approval of the PMA

D) Within 2 years following the PMA approval

C) Prior to approval of the PMA

Regulatory Reference: 21 CFR 807

Devices that are exempt from premarket notification are:

A. All Class I devices

B. Some Class I devices

C. Some Class I devices and some Class II devices

D. All Class I devices and some Class II devices

C. Some Class I devices and some Class II devices

Regulatory Reference: 21 CFR Parts 862 -- 892

A manufacturing process requires purified water to produce several finished Class I exempt and Class II 510(k) medical devices. The water is tested monthly by quality control (QC). Since results have consistently been within specifications, the product is sent to distributors before QC results are final. Over the past six months quality test results have been getting closer to the specification limit. Internal review determined that QC testing should now take place weekly. This information should be provided to FDA through:

A. A postapproval study report

B. A medical device report

C. This information does not need to be submitted

D. An Annual Report

C. This information does not need to be submitted

Regulatory Reference: 510(k) Memorandum #K97-1 Deciding When to Submit a 510(k) for a change to an existing device. Changes that require review for 510(k) notification include: o Technology/performance changes o Operating principle changes o Material changes o Labeling changes * This scenario does not meet any of these criteria

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA?

A) A PMA

B) A Special 510k

C) An Abbreviated 510k

D) An Annual Report for a PMA

C) An Abbreviated 510k

Regulatory Reference: The New 510(k) Paradigm — Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, Final Guidance, 20 March 1998 and 21 CFR 807.81 (a)(3).