FDA Proposes Earlier Response to 510(k) Applications
The U.S. Food and Drug Administration (FDA) is taking another step in its effort to improve its premarket review program with a proposal to inform medical device manufacturers within 15 calendar days if their 510(k) application is incomplete.
With its draft guidance, the agency is also sharing checklists that it says FDA staff will use in evaluating a 510(k) submission. The 510(k) process is the regulatory pathway by which most medical devices are cleared for market, and has been the subject of criticism by many manufacturers who say it is slow and bureaucratic. .
All 510(k) applications go through an initial review to determine if they are complete. Incomplete applications are returned to the submitter with instructions on what to fix, while complete ones go on to a more substantial review.
“The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability,” reads the draft of what’s called the Refuse to Accept Policy for 510(k)s.
The agency’s current Refuse to Accept policy doesn’t include a timetable for manufacturers to receive an FDA response. The new draft guidance document, which was issued on Aug. 13, says that if the agency does not meet the 15-day window, then the application will be accepted.
The document was issued as part of an overall effort to improve premarket review times. The industry has complained that the 510(k) process, used to clear more than 4,000 applications, takes too long to get devices approved. Seeking to address those concerns and also improve product safety, the FDA launched a 510(k) “action plan” in 2010 to improve it. To receive 510(k) clearance, a manufacturer must prove its device is substantially equivalent to one already legally on the market, a predicate.
The industry agreed to pay more under the FDA’s user-fee program in exchange for better review performance. Congress renewed the program last month for another five years as part of the Food and Drug Administration Safety and Innovation Act.
The guidance document includes new checklists that clarify what the FDA is looking for in a 510(k) submission.
The proposed checklists focus more on “specific content” needed in a submission instead of “defining broad issues or principles.” As such, the FDA says, the new checklists will prove more efficient.
The checklists for the initial review include considering whether the “indications for use” and the “fundamental scientific technology” are the same as the predicate device.
During the initial review, the agency only assesses the completeness of the application, and examines the quality of the data during a more substantial review.
The public has 45 days to comment on the document, which can be found here (PDF).
Posted: August 14, 2012