RAPS Practice Test Questions Questions and answers with 100% accuracy(GUARANTEED SUCCESS)

A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented 1/3 of its subjects properly. What is the FIRST thing the company needs to do?

A. Stop the entire study

B. Inform FDA and ask for guidance

C. Re-train the study staff, including the principle investigator at that site on GCP

D. Re-consent all improperly consented subjects

D. Re-consent all improperly consented subjects

The quality assurance manager of a small company with 12 employees is the company's only internal auditor and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because:

A. Auditor independence has not been ensured

B. There is no one in the company qualified to train the quality assurance manager in quality auditing principles

C. Quality system audits cannot be performed by the same auditor for more than two audits in a row

D. The Audit Reports need to be approved by a second internal auditor not involved with the specific audit

A. Auditor independence has not been ensured

A medical device company is developing a product with drug, biologic and device components. The product and indication have not been classified previously by FDA. What is the most appropriate regulatory pathway?

A. An IDE and PMA should be submitted to CDRH, as the company is a medical device company and is most familiar with medical device application regulations

B. A Request for Designation (RFD) should be sent to Office of Combination Products (OCP) at FDA to determine primary mode of action (PMOA) and assign center with primary jurisdiction

C. An IND and NDA should be submitted to CBER because this is the strictest regulatory pathway

D. The company should submit a marketing application to the appropriate FDA center based on the company's determination of primary mode of action (PMOA)

B. A Request for Designation (RFD) should be sent to Office of Combination Products (OCP) at FDA to determine primary mode of action (PMOA) and assign center with primary jurisdiction

When multiple facilities are involved in a Class III device's design, assembly or processing, the PMA holder should do all of the following EXCEPT:

A. Ensure the quality systems in all facilities are in compliance with 21 CFR 820 regulations, as applicable

B. Include in the PMA submission a complete description of the device's manufacturing, processing, packing, storage and installation methods

C. Provide written authorization to reference the Device Master File information from a contracted facility

D. Submit quality system information only for the facility involved in the design of the device

D. Submit quality system information only for the facility involved in the design of the device

A company is submitting a PMA for a permanent implant. The company has performed biocompatibility testing based on ISO requirements and believes the package is complete. Which of the following testing does the company absolutely need to demonstrate long-term safety of its device:

A. Intracutaneous irritation

B. Genotoxicity

C. Acute toxicity

D. Carcinogenicity

D. Carcinogenicity

A device that has just received marketing approval outside the US is to be shipped from the US to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor, who confirms the product has not yet been shipped and is still at its warehouse. Company XYZ requests the foreign distributor return the device immediately. This activity described is an example of a:

A. Market withdrawal

B. Stock recovery

C. Class I recall

D. Class III recall

B. Stock recovery

All of the following are considered raw data in a preclinical study EXCEPT:

A. Final Pathology Report

B. Records of quarantine and animal receipt

C. Animal data entered into animal chart

D. Computer printout derived from data transferred to computer media from lab data sheets

D. Computer printout derived from data transferred to computer media from lab data sheets

Your Notified Body is classifying your device differently from you assessment. After reviewing the classification rules, you are certain your classification is correct; however, the Notified Body is not willing to reconsider. What is the BEST strategy to resolve this situation?

A. Change Notified Body

B. Discuss with the Notified Body the reasons for your opinion

C. Ask the Notified Body to get an opinion from its Competent Authority

D. Sign the Declaration of Conformity and CE mark your device

C. Ask the Notified Body to get an opinion from its Competent Authority

The Clinical Investigation Plan (CIP) must include:

A. A clinical investigator's brochure

B. A clinical investigation protocol

C. The clinical investigator's qualifications

D. A copy of the informed consent form

B. A clinical investigation protocol

The marketing department asks your opinion regarding shelf-life labelling for a new medical device to be able to place it on the market as soon as possible. Which of the following should you advise the marketing department to do?

A. Do not put a "use-by" date on the device

B. Perform prospective accelerated aging studies for the minimum time periods customers will accept

C. Label as they see fit, to be followed by retrospective studies using real time experience

D. Find out what shelf life is used by the competition

B. Perform prospective accelerated aging studies for the minimum time periods customers will accept

A clinical trial of a medical device can begin how many days after notification is sent to the Competent Authority?

A. 30 days

B. 45 days

C. 60 days

D. As soon as Ethical Committee approval is received

C. 60 days

A US manufacturer CE marks its Class IIa medical device and labels it in English, French, German, Italian and Spanish. A French based distributor has a contract with the company to distribute, market and supply the product in the UK, France, Germany, Italy and Spain. A hospital in Sweden calls the distributor requesting a regular supply of the product. The distributor should:

A. Notify the manufacturer and request the label be changed to include Swedish.

B. Supply the product as labelled since English is understood in Sweden.

C. Not supply into Sweden until a local distributor is appointed.

D. Translate the label into Swedish and ship the product.

A. Notify the manufacturer and request the label be changed to include Swedish.

A company is planning to launch its new List B (Annex II) IVD. Which of the following actions should the regulatory professional recommend to the company?

A. Obtain Notified Body approval of the technical documentation and the quality system

B. CE mark the device using the "self-certification" route

C. Ensure that the Notified Body conducts batch release and examination of the dossier design

D. Conduct performance evaluation in accordance with common technical specifications

A. Obtain Notified Body approval of the technical documentation and the quality system

Which of the following BEST demonstrates conformance with the Essential Requirements for a Class IIa device?

A. Test lab results that are authorised by the state Competent Authority

B. Testing conducted by the manufacturer showing conformance to harmonised standards

C. It is not necessary to show conformance through testing because application of standards is voluntary

D. Testing conducted by the manufacturer showing conformance to international or national standards.

B. Testing conducted by the manufacturer showing conformance to harmonised standards

A mfger of a permanently implanted active device is seeking guidance on conformance to Essential Requirements. What advice would you give?

A. Conformance to 90/385/EEC is needed

B. Conformance to 93/42/EEC is needed

C. Conformance to 98/79/EC is needed

D. For active implantable devices, CE Mark is not required

A. Conformance to 90/385/EEC is necessary

The internal audit area of a company is itself due for an internal review and audit. The internal audit procedure was written by an external regulatory/quality consultant. The quality manager is responsible for setting the internal audit schedule, ensuring audit documentation is complete and that actions are taken. The BEST person to conduct this audit is the:

A. Document control manager

B. Regulatory/quality consultant

C. Quality manager

D. Quality inspector who reports to the quality manager

A. Document control manager

The Declaration of Conformity supporting the CE marking of a Class I device includes all EXCEPT:

A. The signature of the NB

B. Identification of directives to which declaration is issued

C. The manufacturer's name and address

D. Product Information (name, type or model number)

A. The signature of the NB

To maintain a valid CE Mark for devices under Annex II, the mfger should:

A. Collect all relevant new information, compile it and submit it to NB at end of three-year period following CE marking

B. Collect all relevant new information, compile it and update technical files for audit and review by NB as required during five-year period following CE marking

C. Collect all relevant new information and update technical documentation at end of five-year period

D. Follow the newly published EN standard to update technical documentation every three years

B. Collect all relevant new information, compile it and update technical files for audit and review by NB as required during five-year period following CE marking

Your company is planning to make a custom-made device for a customer. What CE marking strategy is required to sell the device?

A. DoC and CE Mark are required to market the device

B. A CE Mark is not required, but DoC is required and the Member State may request a list of custom devices in its territory

C. A DoC has been produced by the manufacturer

D. A CE Mark is required and then the CE-marked device can move freely throughout Europe

B. A CE Mark is not required, but DoC is required and the Member State may request a list of custom devices in its territory

A manufacturer is developing bioresorbable plug and delivery devices sold together as a single kit. The bioresorbable plug is placed in the femoral artery to close a puncture site after an angioplasty procedure. The manufacturer has determined through testing the plug is resorbed after 90 days. What is the device's classification?

A. Class IIb device per Annex IX, Rule 6 as it is "wholly or mainly absorbed"

B. Class IIa device per Annex IX, Rule 6 as the device is used for transient use and is not used in the central

circulatory system

C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly absorbed"

D. Class III device per Annex IX, Rule 7 as it is "wholly or mainly absorbed"

C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly absorbed"

NB audit reports the following observation: "Equipment installation/validation protocols do not meet reqs." When reviewing this, the regulatory professional should first:

A. Update the equipment installation/validation protocol and associated SOPs to reflect applicable requirements

B. Ask the auditor to delineate the specific requirements not met by the current protocol

C. Ask the auditor for guidance in updating the protocol

D. Ask the auditor to review the decision

B. Ask the auditor to delineate the specific requirements not met by the current protocol

A US manufacturer classifies its device as Class I non-measuring / non-sterile. After the initial launch of the product in France and subsequent launches during the next two years in Germany and Spain, a user contacts Competent Authority in France claiming the device should be Class IIa. The Competent Authority writes to the manufacturer, the Authorised Representative and the Authorised Representative's Competent Authority in Ireland, stating that the device should be Class IIa. Who has the ultimate authority to decide the correct classification?

A. The French Competent Authority and the Notified Body

B. The Irish Competent Authority

C. The German Competent Authority

D. The Committee of Medical Devices

B. The Irish Competent Authority

A device company has several CE-marked devices for a surgical procedure. The company intends to market the devices as a system or a procedure pack as quickly as possible. What is the most appropriate action for the regulatory professional to take?

A. No action needed as all devices are CE-Marked individually

B. Prepare new technical file for system or procedure pack

C. Prepare new labelling for device system or procedure pack

D. Verify mutual compatibility of these devices, adequate labelling and draw up a declaration for the intended device system or procedure pack

D. Verify mutual compatibility of these devices, adequate labelling and draw up a declaration for the intended device system or procedure pack

Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation. What should the regulatory affairs professional do FIRST to meet the new requirement?

A. Contact the trade association for advice.

B. Communicate with the relevant internal departments.

C. Prepare documents for the files.

D. Request a permanent waiver from the new regulation.

B. Communicate with the relevant internal departments.

In addition to protection, what parameters MUST be considered when selecting the primary package (or a product)?

A. Volume and material

B. Compatibility and safety

C. Safety and efficacy

D. Efficacy and material

B. Compatibility and safety

A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved. During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country. What is the BEST response?

A. Notify the regulatory authority regarding its obligation to honor the commitment to approve the application.

B. Consult with legal department to discuss best course of action.

C. Review the regulatory guidelines to determine how to proceed.

D. Request meeting with regulatory authority to discuss application

D. Request meeting with regulatory authority to discuss application

Which statement regarding export regulations for an approved product is CORRECT?

A. Product must not be in accord with foreign purchaser specifications.

B. Product must not conflict with country laws to which it is intended for export.

C. Product must not be labeled for export on outside of shipping package.

D. Product must not be sold or offered for sale in domestic commerce.

B. Product must not conflict with country laws to which it is intended for export.

In a distribution contract for high-risk devices, which regulatory requirement is the MOST important for the distributor?

A. Local reimbursement requirements

B. Service operation procedures

C. Training program for sales people

D. Written procedure for product traceability

C. Training program for sales people

A company is considering developing a device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

A. Adverse event reports

B. Clinical experience

C. Clinical investigations

D. Literature search

C. Clinical investigations

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A. Allow doctors to use product for off-label indication

B. Communicate with sales department to stop using materials

C. Contact the marketing department to recall the product.

D. Request doctors stop using product for off-label indication

B. Communicate with sales department to stop using materials

Who has the PRIMARY responsibility for recall of products with quality defects?

A. Consumer

B. Distributor

C. Manufacturer

D. Regulatory authority

C. Manufacturer

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

A. Documented agreement

B. Frequent communication

C. Early collaboration

D. Follow-up meeting after submission

B. Frequent communication

A company receives multiple complaints regarding text included on a recently launched label. What action should the regulatory affairs professional take FIRST?

A. Recommend immediate product recall

B. Compare approved text with product label

C. Notify the regulatory authority

D. Inform the production team

B. Compare approved text with product label

A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect is MOST important to consider?

A. Expiration date

B. Relevance to regulations

C. Revision history

D. Scope and level of detail

B. Relevance to regulations

Global company obtained a patent for a newly marketed product. What would be the BEST advice to protect the patent in other countries?

A. Use the Madrid system.

B. Use the community patent system.

C. File patents of interest in target countries.

D. File design patents in target countries.

C. File patents of interest in target countries.

Company is developing a device-drug combination product. Which should be evaluated FIRST to determine app guidance docs?

A. Approved indications of the drug

B. Determination of primary mode of action

C. Determination of product design deliverables

D. Guidance documents for the device

C. Determination of product design deliverables

According to ISO 14971, what is the FIRST step when developing a risk management plan for a device?

A. Risk estimation

B. Risk analysis

C. Risk control

D. Risk management

B. Risk analysis

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A. Resubmit the entire package

B. Inform upper management

C. Contact legal department and ask how to proceed

D. Verify the procedure in the regulation for the corrections

D. Verify the procedure in the regulation for the corrections.

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

A. Quality improvement

B. Quality assurance

C. Clinical affairs

D. Regulatory agency

B. Quality assurance

One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

A. "Given advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."

B. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."

C. "We disagree with advisory committee's decision because committee neglected thorough safety analysis we provided."

D. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

B. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."

During an audit of a contract mfging facility, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract mfger. Which action is MOST appropriate for regulatory affairs professional to take?

A. Allow the auditor access to the room and records due to the current audit.

B. Allow the auditor accompanied access to the room to retrieve the records.

C. Deny the auditor access to the room and retrieve only the requested records

D. Deny the auditor access to the room and records due to confidentiality concerns.

B. Allow the auditor accompanied access to the room to retrieve the records.

What source should the regulatory professional consult to determine when a product's patent and exclusivity will expire?

A. Federal Register

B. The Orange Book

C. Patent and Trademark Office

D. Copyright Office

B. The Orange Book

A company is filing for PMA of a Class III device. Which of the following information MUST be provided?

A. Bioequivalence Information

B. Electronic CTD Specifications

C. Paragraph IV Certification

D. Summary of Studies

D. Summary of Studies

Which of the following medical device entities is required to register its establishment?

A. Contract packager

B. Domestic distributer

C. Medical device salvager

D. Reprocessing facility

D. Reprocessing facility

An FDA reviewer contacts a regulatory professional with a lengthy list of questions regarding a submitted 510(k) application. Some of the information is not readily available and may require additional data collection. What is the BEST course of action for the regulatory professional?

A. Request a meeting with the district office

B. Request a meeting with the panel

C. Respond to the request within 90 days

D. Send a letter with anticipated response time

D. Send a letter with anticipated response time

Ensuring a medical device meets defined user needs and intended use is accomplished through which type of validation?

A. Design

B. Device

C. Process

D. Product

A. Design

Record keeping requirements for marketed products are intended to provide assurance of which of the following?

A. Continued labeling claims

B. Field performance

C. Maintenance of product safety

D. Traceability in distribution

D. Traceability in distribution

Which of the following changes can be submitted without an updated batch record for a modified release product?

A. Component change: deletion of color/flavor

B. Equipment change: alternate equipment, same design

C. Process change: adjustment of equipment beyond

D. Site change: same contiguous campus

A. Component change: deletion of color/flavor

A regulatory professional is negotiating with the FDA on a product's final labeling. The company's management is adamant about including a claim on the labeling, while FDA is proposing a more restrictive claim. What is the regulatory professional's BEST course of action?

A. Accept the FDA's proposed labeling

B. Contact the center's director

C. Contact the ombudsman

D. Negotiate with the review division

D. Negotiate with the review division

Which class of devices has no regulatory quality system req?

A. Class I

B. Class II

C. Class III

D. Class IV

A. Class I

A new Class III medical device technology is developed by a company, and the company wishes to market the product in the shortest possible time. What first course of action should the regulatory professional recommend?

A. Define the purpose of the product so it is a Class IIb

B. Work with a physician to complete the Special Access

C. Test it in a non-EU country under the Helsinki

D. Collect required clinical data

D. Collect required clinical data

Which of the following is required for all medical devices?

A. EC type examination certificate

B. Multilanguage labeling

C. NB involvement

D. Technical documentation

D. Technical documentation

What does a regulatory professional need to address when preparing an internal audit plan?

A. The audit scope, importance of process, findings from previous audits, and selection of auditors

B. The audit scope, findings from previous audits, selection of auditors, and follow up activities taken with verifications

C. The findings from previous audits, selection of auditors, and follow up activities taken with verifications

D. The importance of the process, findings from previous audits, and follow up activities taken with verifications

A. The audit scope, importance of process, findings from previous audits, and selection of auditors

What information is included in the Official Journal of the European Union?

A. Draft guidelines relevant to pharmaceuticals

B. Notices of product recalls in EU

C. Proposed and final EU legislation

D. Summaries of final EU legislation in every EU language

C. Proposed and final EU legislation

To whom is the MDD 93/42/EEC addressed?

A. CA

B. Manufacturers

C. EU Member States

D. NB

C. EU Member States

When can a clinical investigation begin for a Class I device with Ethics Committee approval?

A. Immediately in a new investigational site

B. Immediately after date of notification

C. Sixty days after date of notification

D. Following compliance with Annex IX of the MDD

B. Immediately after the date of notification

A device contains electrical parts that could create EMC interference. The mfger intends to CE mark the device under MDD 93/42/EEC. Which of the following is CORRECT?

A. CE marking under MDD 93/42/EEC is sufficient

B. CE marking under 93/EEC is incomplete

C. The manufacturer needs to conform to MDD 89336E

D. The manufacturer needs to conform to EN ISO 60601

A. CE marking under MDD 93/42/EEC is sufficient

An article published in scientific journal based on experiences in Korean hospital indicates there are problems with use of a mfger's CE-marked device. Medical intervention was necessary to prevent serious injury; however, it was determined FSCA is not necessary. Whom should mfger inform of the situation?

A. CA

B. NB

C. EU Commission

D. No reporting is required

D. No reporting is required

A manufacturer sells 1,500 devices in two months following launch. A user, but not a patient, is seriously injured while using the device. Investigation reveals the cause is an error in a software subroutine that has a one in 195,000 chance of happening. Management is concerned about how the incident may result in serious problems in market. What recommendation is MOST appropriate for regulatory professional to make to management?

A. Complete a product recall for the 1,500 medical devices

B. Complete a corrective action following the manufacturer's procedures

C. Discuss the incident with authorities, explaining no FSCA

D. Discuss the incident with the authorities and send an advisory letter to each customer

D. Discuss the incident with the authorities and send an advisory letter to each customer

A product change of a Class III medical device requires NB approval if the change meets which of the following criteria?

A. It affects the conformity with essential requirements or conditions prescribed for use of the product.

B. It affects the quality and effectiveness or concerns

C. It introduces a new risk not previously recorded

D. It serves as a significant change in the product

A. It affects the conformity with essential requirements or conditions prescribed for use of the product.

A US based manufacturer produces a Class I medical device with a CE mark that is sold in Germany. The authorized representative is located in the Netherlands. An identical medical device is sold outside of the EU. An incident is reported in Japan and leads to an FSCA. The US based manufacturer immediately identifies the problem and makes a change to a mold to prevent future incidents. Whom should the US based manufacturer inform of the situation?

A. Appropriate authorities outside the EU

B. CA in Germany

C. CA in Netherlands

D. NB

C. CA in Netherlands

From device manufacturer's point of view, what is the purpose of a first level appeal?

A. To clarify two conflicting policies

B. To reassess an original decision

C. To reinterpret a guideline

D. To address any issues

B. To reassess an original decision

To comply with ISO standards, which components of doc management are required?

A. Change control and certification control

B. Control of document and control of records

C. QA and management control

D. QC and control of records

B. Control of document and control of records

Which standard contains guidance on biocompatibility for materials used on medical devices?

A. ISO 14155

B. ISO 13485

C. ISO 10993

D. ISO 980

C. ISO 10993

Adverse event has been reported in connection with a device. When assessing link between device and adverse event, which is LEAST relevant?

A. Complaint trends from users

B. Cost of medical device replacement

C. Info of previous, similar events

D. Opinions from healthcare professionals

B. Cost of medical device replacement

Which of the following is BEST identified as a multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality?

A. Design space

B. Manufacturing controls

C. Operating ranges

D. Specification

A. Design space

Which products covered in GHTF's guidance on labeling?

A. IVD devices

B. Medical devices

C. Medical and IVD devices

D. Pharmaceuticals and medical devices

C. Medical devices and IVD devices

Company X and Company Y each have an approved product for the treatment of a particular disease. Although both product labels are similar, Company Y believes that Company X is promoting its product as superior to Company Y's product. Which is the appropriate FIRST course of action that Company Y should take against Company X?

A. Begin false claims litigation

B. Begin promoting Company Y's product as superior

C. Perform a through analysis of the promotional materials of both products

D. Report Company X to the regulatory authority

C. Perform a through analysis of the promotional materials of both products

A device licensed in Canada led to serious deterioration of a patient's health in US. As a result of investigation, it was discovered product specification for sterility for this particular lot was affected. Event and proposed corrective actions were reported to FDA. US based regulatory professional informs Canadian based regulatory professional about this occurrence and indicates affected lot was marketed only in the US. Which of the following recommendations should the Canadian based regulatory professional make to the organization?

A. File the incident in the complaints data

B. Report the incident to the company's president

C. Report the incident to the HPFBI

D. No action is required

C. Report the incident to the HPFBI

During a product recall, what is a PRIMARY role of the Health Protection Branch?

A. To inform healthcare prof of health decisions

B. To inform other reg agencies regarding org's mistakes

C. To monitor effectiveness of org's recall actions and assign Health Hazard Classification

D. To monitor other regulatory agency's to determine effect

C. To monitor the effectiveness of the organization's recall actions and assign appropriate Health Hazard Classification

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following is MOST appropriate for improving product life cycle management?

A. Utilize STED template to complete global registrations

B. Initiate a global submission process after all design elements final

C. Identify countries where specific requirements exist during the product development phase

D. Plan regulatory approval update meetings with team

C. Identify countries where specific requirements exist during the product development phase

Which of the following is TRUE regarding an adulterated medical device?

A. Device fails to comply with any paragraph of the QSR

B. Device has misleading or incorrect information

C. Device lists FDA approved on 510(k)

D. Device does not have a cleared 510(k)

A. Device fails to comply with any paragraph of the QSR

How is labeling reconciliation during manufacturing BEST accomplished?

A. Accounting for product labeling pre- and post-processing

B. Physical separation from other product processes

C. QA inspection of the work area

D. Statistical sampling procedure of the final product

A. Accounting for product labeling pre- and post-processing

A company claims compliance to a harmonized standard in the essential requirements checklist for a Class III device. The harmonized standard is being revised. What are the MOST appropriate actions for the regulatory professional to take to ensure compliance with revised standard?

A. Identify the most suitable person to review the standard. Instruct that individual and a QA rep to make modifications to comply. Follow-up prior to the effective date of the revised standard.

B. Obtain a copy of revised standard. Perform gap analysis. Agree and issue an action plan for completion prior to effective date of revised standard. Inform management of revision.

C. Review the revised standard and analyze any gaps. Alert departments that need to implement changes to ensure continued compliance with the revised standard. Inform management of the revisions via the change control process.

B. Obtain a copy of revised standard. Perform gap analysis. Agree and issue an action plan for completion prior to effective date of revised standard. Inform management of revision.

A manufacturer's Class I sterile device needs a labeling update to add a warning. What is the role of the NB in this situation?

A. Evaluate the sterilization process

B. Issue an EC-type examination certificate

C. Review the updated labeling

D. The NB is not involved

A. Evaluate the sterilization process

The number of times a recognized hazardous situation occurs when a device is used as intended is higher than the manufacturer expected. Which action should the manufacturer take?

A. Immediately recall the product

B. Continue to gather data to see if this trend continues

C. Revise labelling to inform user

D. Feed this information back to the risk management process

D. Feed this information back to the risk management process

A France-based hospital informs a German medical device manufacturer that a component is missing in two out of 10 kits from a single lot. The missing part can be replaced by the hospital during the procedure. The manufacturer decides to virtually inspect the kits and replace the missing part. To resolve the issue, what action should the manufacturer take?

A. Inform the manufacturer's NB

B. Inform the CA in Germany

C. Inform the CA in UK

D. Initiate the manufacturer's CAPA process

D. Initiate the manufacturer's CAPA process

Which standards are widely used by international regulatory agencies as the foundation for assessing a company's ability to manufacture medical devices?

A. ISO 9001, ISO 14971

B. ISO 13485, ISO 14971

C. QSR, ISO 13485

D. STED, ISO 9000

B. ISO 13485, ISO 14971

While compiling regulatory submission for life-sustaining device, the regulatory professional notices risk management file is incomplete and risk information is contained in R&D, mfging, and QA docs. What is the MOST practical recommendation to ensure a timely regulatory approval?

A. Confirm risk management file contains copies of R&D, mfging, and QA docs

B. Confirm risk management file references information contained in the R&D, mfging, and QA docs

C. Generate a summary of the risk management information

D. Take no action because available risk management documentation exists

B. Confirm risk management file references information contained in the R&D, mfging, and QA docs

What is the BEST source for determining the format of an MAA intended for submission to an HA?

A. GMP

B. Local HA guidelines

C. ICH

D. WHO

B. Local HA guidelines

According to GHTF, what class of medical device would NOT require a premarket on-site inspection?

A. Class A

B. Class B

C. Class C

D. Class D

A. Class A

Upon the submission of an adverse incident, the FDA identifies a complaint trend for a company's surgical mesh products. The FDA requests the company's US based affiliate to change the IFU and incorporate an additional warning. In addition, the US based affiliate will send out a field notice to its customers. The product is also available in Canada. The regulatory professional at the US based affiliate notifies the Canadian-based regulatory professional to check on the regulatory impact in Canada. Which of the following documentation does NOT need to be completed?

A. Amendment submission

B. Mandatory problem report

C. Market retrieval of product

D. Recall notification

C. Market retrieval of product

A company establishes new device indication for consumer disposable products. RA professional is asked to give a training session on these products to sales reps. Which of the following subjects is the MOST important to discuss?

A. Labeling

B. Regulatory application summary

C. Risk management process

D. Safety related reporting

A. Labeling

Company wishes to expand labeling to include new indication. What action should regulatory professional take FIRST?

A. Contact review division to determine if a 510(k) or PMA should be prepared

B. Contact review division to determine correct process

C. Prepare a 510(k) claiming SE to a predicate

D. Prepare a 510(k) claiming no change

A. Contact the review division to determine whether a 510(k) or PMA should be prepared

During a routine inspection of the promotional materials of a medical device, the regulatory professional notices a factual error. This error could potentially lead to an incorrect usage of the device. A search of the company's safety database finds multiple reported events due to the error, none of which was serious. The IFU for the medical device contain the correct information. According to GHTF guidelines, does this error need to be reported?

A. Yes, the mistake in the promotional materials is misleading the users of the medical device

B. Yes, the misinformation could lead to death or serious injury to a patient

C. No, the IFU contains the correct information

D. No, there were no reports of any serious events

B. Yes, the misinformation could lead to death or serious injury to a patient

A company currently sells a third version of a non-implantable device introduced four years ago. The company wishes to destroy records of second version. Which of the following is CORRECT?

A. All records can be destroyed

B. Mfging records can be destroyed

C. Sales records can be destroyed

D. No records can be destroyed

D. No records can be destroyed

A company plans to use risk management tools to analyze a manufacturing process in order to identify high-risk and critical parameters. What type of analysis should be used?

A. Failure mode effects

B. Fault tree

C. Preliminary hazard

D. Process capability

A. Failure mode effects