CGMPS module 13

What are medical devices defined as?

Instruments intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals. It is intended to affect the structure or any function of the body

What is the main difference between medical devices and drugs?

Drugs depend on chemical action and need to be metabolized, medical devices dont

Who recognizes/defines medical devices in the U.S?

National formulary, or the United States Pharmacopeia (including any supplementary bodies to them)

True or False: Medical devices have direct therapeutic effect on the body

False, they have no chemical or metabolic affects on the body

Do medical devices exert their effects locally or globally across the body?

Medical devices operate locally

Do some medical devices even have to contact the patient to exert their affect?

No, some do not need patient contact exert their affect

True or False: A medical device can be a instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article including any component, part, or accessory.

True, might wanna remember the list of random things, basically its not a drug ig

What is an example of an in vitro reagent medical device?

At home pregnancy tests, glucose test, dyes used during CAT scans or MRIs

What are some examples of non invasive devices?

Diagnostic tests and instruments

What are some examples of invasive medical devices?

Implants, stents, pacemakers

Are calculators counted and regulated as medical devices?

APPARENTLY, THEY ARE, SO YES because they are used in the lab

What part of CFR 21 talks about regulating calculators as medical devices?

CFR 21 part 862 subpart C, section 862.2100

What would all these items be considered?

Regulated medical devices

What was the Dalkon shield incident during the 70s?

Dalkon shield was a contraceptive intrauterine device. It had 2.8 million users in the U.S. despite manufactures knowledge of safety problems. It promoted infection of the uterus, fallopian tubes, and ovaries that can lead to abortion and infertility. Injured many users leading to multiple lawsuits and compensation in the millions. MAIN ISSUE: wicking issue with the tail getting caught into the vaginal wall and collecting bacteria, promoting infection. Manufacturers didn’t pull it back out of greed

What did the dalkon shield crisis lead to?

The medical device regulation act AKA The medical device amendments act to the FFDCA

What did the medical device regulation act do?

Congress extends regulatory compliance (CGMPS) to cover medical devices

What other acts or amendments were enacted on medical devices following the medical device regulation act of 1976

1. Safe medical devices act of 1990

2. Medical device amendments of 1992

3. 1996 - final rule on cGMP requirements for medical devices

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

What does CFR 21 part 820 talk about?

Quality System Regulation (medical device regulation)

True or False: Quality systems as defined in 21CFR 820 apply to the research process

False, they do not apply to the research process

What do Quality systems regulations apply to?

Medical devices classes I-III

How does quality system regulation apply to class I medical devices?

Quality system regulations only apply to the manufacturing process

How does quality system regulation apply to class II and III medical devices?

Quality system regulations apply to both device development and manufacturing processes

While some devices are exempt from cGMPs, what are they not exempt from?

Keeping complaint (problems) files and general requirements concerning records (MUST DOCUMENT EVERYTHING)

Are we covering every subpart of 21 CFR 820?

yes . . .

What does subpart A of section 820 talk about?

General Provisions

What does subpart A of section 820 outline?

Medical devices have to follow QuIPS and be compliant with FFDCA. Failure to do so means device is adulterated and involved parties will be subject to regulatory actions

What is section 820 subpart B about?

Quality Systems requirements

What is 820.20 titled?

Management Responsibility

What does CFR 21 part 820.20 talk about?

Management must “Establish quality systems procedures” by:

1. Establish quality policy and ensure that it is understood and implemented

2. Organization with clear responsibilities and authorities

3. Review the effectiveness of the quality system at defined intervals

   1. Audits, rework records, QC test results, final inspection records, service records, customer complaints

What is part 820.22 titled and talk about?

Quality Audits, they must be performed and results must be documented, need for CAPA

What is part 820.25 titled and talk about?

• Personnel, must have sufficient personnel with proper ETE

• Must identify need for training, written procedures for training, and document training

• Personnel should also be made aware of defects or errors that may be encountered as part of their job functions

What is part C of section 820 titled and talk about?

• Design Controls, basically quality system controls do not apply to research, they start with development process

• SOP for design controls should clearly define the beginning point where design controls will start and apply

• Applies to class II and III devices and a few class I devices

What are the eight components of design control?

Design:

1. development planning

2. input

3. output

4. review

5. verification

6. validation

7. transfer

8. changes

What is included in the design of development planning?

1. Timelines for developmental strategy and reviews

2. Deliverables for each stage

3. Personnel and responsibility assignments

What is included in Design input?

1. Everything is documented, reviewed, and reviewed

2. Intended use

3. User/patient/clinical requirements

4. Human factors

5. Performance characteristics/specifications

6. Evaluate components and suppliers

7. Packaging, labels, and user instructions

What is included in design output?

1. Finished design

2. Evaluate conformance to input requirements/acceptance criteria

3. Basis for the device master record (DMR)

What is included in the design Review?

1. Does the design meet customer needs

2. Have procedures/individuals assigned for design review

3. All review activities/results/individuals that participated must be documented

4. Address manufacturability and reliability issues

5. Address human factors issues

What is included in design verification?

1. Confirm that design outputs meet the input requirements by reviewing data from tests, inspections, and analysis

   1. Kinda be like initiating a change control if a discrepancy is found

2. Procedure for resolving discrepancies

   1. CAPAs or implementing a change control

What is Design Validation include?

• Validation methods, reports, and review conducted according to SOP

• Performed under defined operating conditions on initial production units - test under actual or simulated use conditions

• Ensure that devices conform to user needs and intended uses

What does design transfer include

• Written plan for transfer of design components to manufacturing

• Develop manufacturing facilities and utilities

• Develop and validate manufacturing processes

• All personnel adequately trained

• Assure that all manufacturing and QS function according to specs

What are included in design changes?

• Tracked, verified, validated, and approved before implementation

• Corrective actions complete (change controls, CAPAs)

• DHF (design history file) includes all revisions

What is a DHF?

Design history file, keeps record of all changes made

What is subpart G of section 820 about?

Production and process controls

What is a big difference in acceptance activities for medical devices compared to drugs?

Whether your medical device is accepted or rejected, it must be quarantined.

If it was accepted, wait until release to stop quarantining

If it was rejected, quarantine so it does not get used or released

Review inspectional approach, some good flashcards

Review Seven systems slide