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Questions and Answers

Which of the following is a requirement of the Quality System Regulation (QSR) for medical devices (21CFR 820)?

Management must review the Quality System at least quarterly

An annual report on quality measures (correct)

Management to make a commitment to quality

A Quality Plan that defines how quality will be met

What is the required time frame for reporting unexpected properties of an approved drug product?

Within 3 working days to the local FDA district office

In the annual report

Within 7 calendar days to the local FDA district office (correct)

Within 15 calendar days to reviewing FDA office

Which of the following credentials would allow a non-MD to conduct clinical trials according to FDA policy?

Doctor of Pharmacy (PharmD)

Doctor of Osteopathic Medicine (DO)

Doctor of Dental Science (DDS)

Medical Doctor (MD) (correct)

Which of the following is NOT an objective of a pre-approval inspection?

Identify potential marketing strategies Signup and view all the answers

What is the purpose of a Market Withdrawal involving no violation or minor violation of the Federal Food, Drug & Cosmetic Act?

To physically remove the device for repair or modification Signup and view all the answers

What action does Stock Recovery refer to in relation to a medical device?

Recovering devices that have not left the manufacturer's control Signup and view all the answers

Which action is NOT an example of a 'prior approval' supplement for a marketed product?

Adding a precaution to label Signup and view all the answers

What is considered an example of a 'Changes Being Effected' supplement for a marketed product?

Adding/strengthening a contraindication or warning Signup and view all the answers

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

Labeling and packaging materials that remain at the end of a production shift Signup and view all the answers

What is NOT considered a characteristic of Advisory Committee meetings?

Advisory Committee meetings only occur in the product approval stage Signup and view all the answers

Which class of device is an OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks?

Class 1 Signup and view all the answers

In developing a product to treat a serious and life-threatening disease, what regulatory strategy might you select before commencing Phase 3 studies?

Request Fast Track Designation Signup and view all the answers

Why should labeling and packaging materials that do not meet the approved specifications be rejected according to GMPs?

To maintain consistency in product quality Signup and view all the answers

What role do Advisory Committee meetings play in the FDA's regulatory process?

They provide recommendations based on expert consultations Signup and view all the answers

Why is it important to differentiate gang printed labeling by size, shape, or color?

To ensure the products are easily identifiable Signup and view all the answers

Which amendment mandated the establishment of efficacy as well as safety before a drug could be marketed?

Amendment as a Result of Thalidomide Tragedy Signup and view all the answers

Is it true that the submission to FDA must demonstrate that the medical device to be marketed is safe and effective?

True Signup and view all the answers

What is the FDA processing time for a 510(k) submission?

90 days Signup and view all the answers

Does 510(k) provide the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or marketing application?

No Signup and view all the answers

Are Institutional Review Boards (IRBs) likely to approve all submissions?

No, never Signup and view all the answers

'Center for Biologics Evaluation and Research' is primarily focused on medical devices. Is this statement correct?

False Signup and view all the answers

Based on the text, is a violative device likely to cause adverse health consequences?

No Signup and view all the answers

'IDE' stands for:

'Investigational Device Exemption' Signup and view all the answers

What is the first advice given by a Regulatory Affairs professional when a company wants to conduct a small exploratory study for an alternate dosing regimen for an approved drug/approved indication?

The study must be conducted under an IND Signup and view all the answers

According to GMP regulations, what is the responsibility of the quality control unit?

Approving and rejecting raw materials, components, label, drug products, procedures, and specifications Signup and view all the answers

What criteria must written procedures (SOPs) for production and process control deviation meet?

Must be written by the production function Signup and view all the answers

In what circumstances may a field recall action be expected?

Identification of a safety issue with the product Signup and view all the answers

What could be a consequence of not obtaining approval under Subpart H for drugs intended for serious or life-threatening illnesses?

Inability to market the drug for approved indications Signup and view all the answers

Why is it essential for written procedures to exist for production and process controls?

To satisfy regulatory requirements Signup and view all the answers

What role does the quality control unit play in ensuring product quality according to GMP regulations?

Approving or rejecting raw materials, components, label, drug products, procedures, and specifications Signup and view all the answers

Why should a company conduct studies under an IND when exploring alternate dosing regimens for approved drugs?

To ensure patient safety Signup and view all the answers

Study Notes

FDA Regulations

The Quality System Regulation (QSR) for medical devices (21CFR 820) requires management to make a commitment to quality and identifies a quality representative, but does not require quarterly reviews.

Reporting Adverse Events

Sponsors of approved drug products must report unexpected properties suggesting chemical, physical, or bacteriological changes within 3 working days to the local FDA district office.

Clinical Trials

Non-MD individuals can conduct clinical trials as long as an individual listed as a co- or sub-investigator has MD, DO, or DDS credentials.

Pre-Approval Inspections

Objectives of a pre-approval inspection include assessing cGMP compliance, collecting samples for analysis, and conducting scientific review of data to assess safety and efficacy.

Guidance Documents

The FDA can obtain industry input for preparing a new guidance document by conducting talks with trade associations.

FD&C Act

Establishment Registration is not a General Control under the FD&C Act.

Supplements

A "prior approval" supplement is required for manufacturing process changes or adding/deleting a precaution to the label, but not for changes to the product sterility or product labeling.

Labeling

Product labels should be rejected if they do not meet approved specifications or are obsolete/outdated.

Advisory Committee Meetings

Advisory Committee meetings are a way for FDA to consult with outside experts, but the FDA does not have to follow their recommendations.

Device Classification

An OTC denture repair kit is a Class 1 device.

Regulatory Strategy

Requesting a Special Protocol Assessment is a regulatory strategy prior to commencing Phase 3 studies for a product treating a serious and life-threatening disease.

Kefauver-Harris Amendments

The Kefauver-Harris Amendments mandated the establishment of efficacy as well as safety before a drug could be marketed, and introduced stricter agency control over drug trials.

510(k) Premarket Notification

A 510(k) is submitted to FDA to demonstrate that a medical device is safe and effective or "substantially equivalent" to a legally marketed device, with a 90-day processing time.

Institutional Review Boards (IRBs)

IRBs are responsible for reviewing and approving clinical trial protocols.

Center for Biologics Evaluation and Research

The Center for Biologics Evaluation and Research is responsible for evaluating biological products.

Accelerated Approval

Accelerated approval can be granted for new drugs for serious or life-threatening illnesses.

Exploratory Studies

A small exploratory study for an alternate dosing regimen for an approved drug/approved indication must be conducted under an IND.

Good Manufacturing Practices (GMPs)

The quality control unit is responsible for approving and rejecting raw materials, components, labels, drug products, procedures, and specifications.

Standard Operating Procedures (SOPs)

Written procedures (SOPs) for production and process control deviation must meet certain criteria, but do not have to be written by the production function.

Field Recalls

Field recall actions may be necessary if certain conditions are met.

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Description

Test your knowledge of the Quality System Regulation (QSR) for medical devices, including requirements for quality commitment, quality plan, and quality representative. See how well you understand the regulations set forth in 21CFR 820.