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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)?
Which of the following is a requirement of the Quality System Regulation (QSR) for medical devices (21CFR 820)?
What is the required time frame for reporting unexpected properties of an approved drug product?
What is the required time frame for reporting unexpected properties of an approved drug product?
Which of the following credentials would allow a non-MD to conduct clinical trials according to FDA policy?
Which of the following credentials would allow a non-MD to conduct clinical trials according to FDA policy?
Which of the following is NOT an objective of a pre-approval inspection?
Which of the following is NOT an objective of a pre-approval inspection?
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What is the purpose of a Market Withdrawal involving no violation or minor violation of the Federal Food, Drug & Cosmetic Act?
What is the purpose of a Market Withdrawal involving no violation or minor violation of the Federal Food, Drug & Cosmetic Act?
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What action does Stock Recovery refer to in relation to a medical device?
What action does Stock Recovery refer to in relation to a medical device?
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Which action is NOT an example of a 'prior approval' supplement for a marketed product?
Which action is NOT an example of a 'prior approval' supplement for a marketed product?
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What is considered an example of a 'Changes Being Effected' supplement for a marketed product?
What is considered an example of a 'Changes Being Effected' supplement for a marketed product?
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According to GMPs, which of the following product labels should be rejected?
According to GMPs, which of the following product labels should be rejected?
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What is NOT considered a characteristic of Advisory Committee meetings?
What is NOT considered a characteristic of Advisory Committee meetings?
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Which class of device is an OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks?
Which class of device is an OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks?
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In developing a product to treat a serious and life-threatening disease, what regulatory strategy might you select before commencing Phase 3 studies?
In developing a product to treat a serious and life-threatening disease, what regulatory strategy might you select before commencing Phase 3 studies?
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Why should labeling and packaging materials that do not meet the approved specifications be rejected according to GMPs?
Why should labeling and packaging materials that do not meet the approved specifications be rejected according to GMPs?
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What role do Advisory Committee meetings play in the FDA's regulatory process?
What role do Advisory Committee meetings play in the FDA's regulatory process?
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Why is it important to differentiate gang printed labeling by size, shape, or color?
Why is it important to differentiate gang printed labeling by size, shape, or color?
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Which amendment mandated the establishment of efficacy as well as safety before a drug could be marketed?
Which amendment mandated the establishment of efficacy as well as safety before a drug could be marketed?
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Is it true that the submission to FDA must demonstrate that the medical device to be marketed is safe and effective?
Is it true that the submission to FDA must demonstrate that the medical device to be marketed is safe and effective?
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What is the FDA processing time for a 510(k) submission?
What is the FDA processing time for a 510(k) submission?
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Does 510(k) provide the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or marketing application?
Does 510(k) provide the opportunity for an applicant to obtain FDA feedback prior to intended submission of an IDE or marketing application?
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Are Institutional Review Boards (IRBs) likely to approve all submissions?
Are Institutional Review Boards (IRBs) likely to approve all submissions?
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'Center for Biologics Evaluation and Research' is primarily focused on medical devices. Is this statement correct?
'Center for Biologics Evaluation and Research' is primarily focused on medical devices. Is this statement correct?
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Based on the text, is a violative device likely to cause adverse health consequences?
Based on the text, is a violative device likely to cause adverse health consequences?
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'IDE' stands for:
'IDE' stands for:
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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?
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?
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According to GMP regulations, what is the responsibility of the quality control unit?
According to GMP regulations, what is the responsibility of the quality control unit?
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What criteria must written procedures (SOPs) for production and process control deviation meet?
What criteria must written procedures (SOPs) for production and process control deviation meet?
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In what circumstances may a field recall action be expected?
In what circumstances may a field recall action be expected?
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What could be a consequence of not obtaining approval under Subpart H for drugs intended for serious or life-threatening illnesses?
What could be a consequence of not obtaining approval under Subpart H for drugs intended for serious or life-threatening illnesses?
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Why is it essential for written procedures to exist for production and process controls?
Why is it essential for written procedures to exist for production and process controls?
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What role does the quality control unit play in ensuring product quality according to GMP regulations?
What role does the quality control unit play in ensuring product quality according to GMP regulations?
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Why should a company conduct studies under an IND when exploring alternate dosing regimens for approved drugs?
Why should a company conduct studies under an IND when exploring alternate dosing regimens for approved drugs?
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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.
