Premarket Submission Pathways Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Premarket Submission Pathways flashcards as text
Which section of a PMA application contains the results of all clinical investigations used to support device safety and effectiveness?
Answer: Section 6 – Clinical investigations
PMA Section 6 (Clinical Investigations) is where all clinical study data, protocols, and results must be reported.
A PMA supplement that involves a new indication for use but uses the same basic device design is classified as which supplement type?
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.
Under the Abbreviated 510(k) program, which document type allows a submitter to reference FDA-recognized consensus standards to satisfy performance requirements?
Answer: Declaration of Conformity
An Abbreviated 510(k) uses a Declaration of Conformity to FDA-recognized standards in lieu of full performance data.
FDA's Breakthrough Device Program is designed to expedite development and review of devices intended for which patient population?
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.
What is the primary regulatory distinction between a 510(k) clearance and a PMA approval?
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.
Which FDA program allows manufacturers to submit a single, modular PMA application in separate sections as data becomes available?
Answer: Modular PMA Program
The Modular PMA Program allows sponsors to submit completed modules of a PMA sequentially, enabling concurrent FDA review.
A 510(k) submitter claims substantial equivalence to a predicate but introduces new technology. Which comparison element must be addressed?
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.