RAC Premarket Submission Pathways 2

Question 1

A manufacturer wants to market a Class II device that is substantially equivalent to a predicate device cleared in 1995. Which submission type is required?

Accepted Answer

510(k)

Answer

Class II devices with a predicate require a 510(k) premarket notification demonstrating substantial equivalence.

Question 2

What is the maximum review period FDA targets for a Traditional 510(k) under MDUFA commitments?

Accepted Answer

90 calendar days

Answer

FDA's MDUFA performance goal for Traditional 510(k) review is 90 calendar days from receipt.

Question 3

Which of the following is NOT a recognized type of 510(k) submission?

Accepted Answer

Expedited 510(k)

Answer

The three recognized 510(k) types are Traditional, Abbreviated, and Special; 'Expedited' is not an official 510(k) category.

Question 4

A De Novo request results in which regulatory outcome if granted?

Accepted Answer

Class II classification with special controls

Answer

A granted De Novo request establishes a new Class II classification with special controls for the device type.

Question 5

Under the Special 510(k) program, what is the primary basis for demonstrating substantial equivalence?

Accepted Answer

Design controls under 21 CFR Part 820

Answer

The Special 510(k) relies on design controls to demonstrate that device modifications do not affect safety or effectiveness.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Premarket Submission Pathways 2