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
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?
Answer: 510(k)
Class II devices with a predicate require a 510(k) premarket notification demonstrating substantial equivalence.
What is the maximum review period FDA targets for a Traditional 510(k) under MDUFA commitments?
Answer: 90 calendar days
FDA's MDUFA performance goal for Traditional 510(k) review is 90 calendar days from receipt.
Which of the following is NOT a recognized type of 510(k) submission?
Answer: Expedited 510(k)
The three recognized 510(k) types are Traditional, Abbreviated, and Special; 'Expedited' is not an official 510(k) category.
A De Novo request results in which regulatory outcome if granted?
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.
Under the Special 510(k) program, what is the primary basis for demonstrating substantial equivalence?
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.
Which premarket pathway is specifically intended for devices that treat or diagnose diseases affecting fewer than 8,000 patients per year in the US?
Answer: HDE
The Humanitarian Device Exemption (HDE) is for devices targeting rare diseases or conditions affecting ≤8,000 US patients annually.
When FDA issues an 'Additional Information' (AI) request during a 510(k) review, what happens to the review clock?
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.