RAC Premarket Submission Pathways 3 — Questions and Answers
Question 1: Which section of a PMA application contains the results of all clinical investigations used to support device safety and effectiveness?
- Section 4 – Nonclinical studies
- Section 6 – Clinical investigations (Correct answer)
- Section 2 – Device description
- Section 8 – Manufacturing information
Correct answer: Section 6 – Clinical investigations
PMA Section 6 (Clinical Investigations) is where all clinical study data, protocols, and results must be reported.
Question 2: A PMA supplement that involves a new indication for use but uses the same basic device design is classified as which supplement type?
- Panel-Track Supplement (Correct answer)
- 180-Day Supplement
- Real-Time Supplement
- Special PMA Supplement
Correct answer: Panel-Track Supplement
Panel-Track Supplements are required when a new indication or labeling change involves clinical data review, often by an advisory panel.
Question 3: Under the Abbreviated 510(k) program, which document type allows a submitter to reference FDA-recognized consensus standards to satisfy performance requirements?
- Declaration of Conformity (Correct answer)
- Predicate comparison matrix
- Risk-benefit analysis
- IDE application
Correct answer: Declaration of Conformity
An Abbreviated 510(k) uses a Declaration of Conformity to FDA-recognized standards in lieu of full performance data.
Question 4: FDA's Breakthrough Device Program is designed to expedite development and review of devices intended for which patient population?
- Pediatric patients only
- Patients with serious or life-threatening conditions (Correct answer)
- Patients in rural areas lacking device access
- Elderly patients with chronic conditions
Correct answer: Patients with serious or life-threatening conditions
The Breakthrough Device Program prioritizes devices that provide more effective treatment or diagnosis of serious or life-threatening diseases.
Question 5: What is the primary regulatory distinction between a 510(k) clearance and a PMA approval?
- 510(k) allows commercial distribution; PMA does not
- PMA requires a finding of reasonable assurance of safety and effectiveness; 510(k) requires substantial equivalence (Correct answer)
- PMA is only for Class I devices; 510(k) is for Class III
- 510(k) requires clinical data; PMA does not
Correct answer: PMA requires a finding of reasonable assurance of safety and effectiveness; 510(k) requires substantial equivalence
PMA requires FDA to find reasonable assurance of safety and effectiveness, while 510(k) only requires substantial equivalence to a legally marketed predicate.
Question 6: Which FDA program allows manufacturers to submit a single, modular PMA application in separate sections as data becomes available?
- Staged PMA Review
- Modular PMA Program (Correct answer)
- Rolling Submission Program
- Pre-Submission (Q-Sub) Program
Correct answer: Modular PMA Program
The Modular PMA Program allows sponsors to submit completed modules of a PMA sequentially, enabling concurrent FDA review.
Question 7: A 510(k) submitter claims substantial equivalence to a predicate but introduces new technology. Which comparison element must be addressed?
- Same intended use and same technological characteristics
- Same intended use and different technological characteristics with no new safety questions (Correct answer)
- Different intended use and same technological characteristics
- Different intended use and different technological characteristics
Correct answer: Same intended use and different technological characteristics with no new safety questions
When technological characteristics differ, substantial equivalence can still be found if the same intended use is maintained and the new technology raises no new safety or effectiveness questions.
RAC Premarket Submission Pathways 3
Which section of a PMA application contains the results of all clinical investigations used to support device safety and effectiveness?