510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!

QUESTIONS

1. What does the 510(k) number mean, and how is it structured?
2. What offices in the CDRH review 510(k) applications?
3. During the substantive review, what day should you expect to hear back from the FDA?
4. If your 510(k) is in interactive review (the clock has not stopped), to whom can you send your communications?
5. How often does the FDA update the 510(k) database?
6. BONUS QUESTION: If the FDA meets all of its performance goals, what is the (theoretical) longest time a submission could take to get through the process?

SCROLL DOWN TO SEE THE ANSWERS

ANSWERS

1. The 510(k) number is assigned by the Document Control Center (DCC). It begins with a “K” followed by 6 digits. The first two digits designate the calendar year the application was received; the last four digits represent the submission number for the year, starting with 0001 and increasing with each new submission.
2. The Office of Device Evaluation (ODE), and the Office of In Vitro Diagnostics and Radiological Health (OIR)
3. Usually by Day 60, the FDA will communicate the Substantive Interaction with the applicant that indicates the FDA will proceed with Interactive Review (the FDA clock is still on) or ask for Additional Information (the FDA clock stops).
4. Your communications can be sent directly to the Lead Reviewer, or the DCC. If any information is submitted to the DCC, a valid eCopy must be included.
5. Weekly – Keep an eye on this database if you are in a very competitive market, or to understand trends of the FDA.
6. 630 days! The FDA will review the submission within 7 days to see if there is a valid e-copy and user fee. If not, the 510(k) will be placed on hold for 180 days before it is deleted. Next, the 510(k) goes through acceptance review. If the submission is not accepted for review (considered RTA), it is placed on RTA Hold for a maximum of 180 days. Moving into the substantive review phase, if additional information is requested at calendar day 60 on the FDA clock, the sponsor has up to 180 days to respond to the AI request. Once the request is submitted, the FDA will then have 30 days to respond. (7 + 180 + 8 + 180 + 45 + 180 + 30) However, assuming the FDA meets their deadlines, much if this timeline is within the control of the sponsor. It behooves you to get your answers quickly, while also making sure they are complete.

The answers for today’s quiz can be found at the link here. Visit this link to view a new simple to follow chart from the FDA on the review timeline for 510(k)s.

Did you score 100%? Tell me your results!

- Sherri