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

PMA

Answer

De Novo

Answer

HDE

Question 2

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

Accepted Answer

90 calendar days

Answer

30 calendar days

Answer

60 calendar days

Answer

180 calendar days

Question 3

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

Accepted Answer

Expedited 510(k)

Answer

Traditional 510(k)

Answer

Abbreviated 510(k)

Answer

Special 510(k)

Question 4

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

Accepted Answer

Class II classification with special controls

Answer

PMA approval

Answer

Class I exemption

Answer

Humanitarian Device Exemption

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

New clinical data

Answer

Published performance standards

Answer

An IDE study

Question 6

Which premarket pathway is specifically intended for devices that treat or diagnose diseases affecting fewer than 8,000 patients per year in the US?

Accepted Answer

HDE

Answer

De Novo

Answer

PMA

Answer

Breakthrough Device Designation

Question 7

When FDA issues an 'Additional Information' (AI) request during a 510(k) review, what happens to the review clock?

Accepted Answer

It is suspended until the sponsor responds

Answer

It continues running uninterrupted

Answer

It resets to day 1

Answer

FDA has 45 days to review the response