RAC Premarket Submission Pathways 3

Question 1

Which section of a PMA application contains the results of all clinical investigations used to support device safety and effectiveness?

Accepted Answer

Section 6 – Clinical investigations

Answer

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?

Accepted Answer

Panel-Track Supplement

Answer

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?

Accepted Answer

Declaration of Conformity

Answer

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?

Accepted Answer

Patients with serious or life-threatening conditions

Answer

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?

Accepted Answer

PMA requires a finding of reasonable assurance of safety and effectiveness; 510(k) requires substantial equivalence

Answer

PMA requires FDA to find reasonable assurance of safety and effectiveness, while 510(k) only requires substantial equivalence to a legally marketed predicate.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Premarket Submission Pathways 3