RAC Premarket Submission Pathways 2 — Questions and Answers
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?
- PMA
- 510(k) (Correct answer)
- De Novo
- HDE
Correct answer: 510(k)
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?
- 30 calendar days
- 60 calendar days
- 90 calendar days (Correct answer)
- 180 calendar days
Correct answer: 90 calendar days
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?
- Traditional 510(k)
- Abbreviated 510(k)
- Special 510(k)
- Expedited 510(k) (Correct answer)
Correct answer: Expedited 510(k)
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?
- PMA approval
- Class I exemption
- Class II classification with special controls (Correct answer)
- Humanitarian Device Exemption
Correct answer: Class II classification with special controls
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?
- New clinical data
- Design controls under 21 CFR Part 820 (Correct answer)
- Published performance standards
- An IDE study
Correct answer: Design controls under 21 CFR Part 820
The Special 510(k) relies on design controls to demonstrate that device modifications do not affect safety or effectiveness.
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?
- De Novo
- PMA
- HDE (Correct answer)
- Breakthrough Device Designation
Correct answer: HDE
The Humanitarian Device Exemption (HDE) is for devices targeting rare diseases or conditions affecting ≤8,000 US patients annually.
Question 7: When FDA issues an 'Additional Information' (AI) request during a 510(k) review, what happens to the review clock?
- It continues running uninterrupted
- It is suspended until the sponsor responds (Correct answer)
- It resets to day 1
- FDA has 45 days to review the response
Correct answer: It is suspended until the sponsor responds
The review clock is placed on hold (suspended) while FDA awaits the sponsor's response to an AI request.
RAC Premarket Submission Pathways 2
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?