What's taking so long?

How long does it take to get device clearance through the 510(k) pathway? Does your 90 days seem to stretch into 160? What’s taking so long?

Your 510(k) leaves your front door with the pages still warm from your printer. It then lands on the front step of the FDA, and they have 15 days to review it to determine if it is acceptable (acceptance review). This acceptance is solely from an administrative perspective. Did you file with the appropriate center? Did you include all the correct sections? Did you present the data in the correct format? If your submission is incomplete they will issue a Refuse to Accept (RTA) Designation and your 510(k) will not be reviewed. If your submission is complete, your 510(k) will be accepted. Upon acceptance, the 90 day FDA review clock begins (substantive review).

To ensure you don’t get an RTA designation, run through the checklists provided at the end of the newly issued draft guidance document “Refuse to Accept Policy for 510(k)s”. Putting together a well-organized and complete 510(k) may also help you speed up the time from when the 510(k) leaves your front door to your clearance letter. If all the sections are complete, the FDA can quickly move your 510(k) from the ‘acceptance review’ pile to the ‘substantive review’ pile.

Now you are in your 90 day substantive review period, the period when the FDA is looking at the quality of the submission to determine substantial equivalence. Sometimes it feels like those 90 days can drag out, disgruntling your investors and delaying your market launch. Recently, many manufacturers have criticized the FDA for increased review times.

In an article written in 2011, the FDA recognized the concerns of industry, and confirmed that total review time is indeed rising. The average time to a 510(k) decision is 140 days. However, when you break it down, the FDA is meeting their 90 day objective 90% of the time, but the total review time is increasing due to companies taking more and more time to respond to Requests for Additional Information (RAI), and more cycles of questioning for each 510(k). A significant portion of RAI's are related to inadequate device descriptions. As the manufacturer, this should be your forte; no one knows your product better than you do. In addition, it is important to adequately address the questions asked by the FDA to avoid repeat inquiries.

So, when you’re wondering what’s taking so long, think back and make sure you have done everything you can to uncover every rock and present a high quality submission. The rest is up to the FDA!

What are your strategies for ensuring speedy device clearance?

- Sherri

For RTA policy and checklists, see the guidance document here: “Refuse to Accept Policy for 510(k)s” http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm315317.htm

For more information on how your 510(k) should be formatted, see the guidance document here: “Format for Traditional and Abbreviated 510(k)s” http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084365.htm

For analysis of 510(k) review times, see the FDA article here: CDRH’s “Analysis Of Premarket Review Times Under The 510(k) Program” http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM263386.pdf