New draft guidance provided by the FDA now makes it easier for the FDA to refuse to accept medical device approval applications if the applications fail to provide certain information. Citing that the previous FDA guidance resulted in the FDA accepting numerous inadequate submissions and investing significant time in requesting additional information from manufacturers to make 510(k) applications complete, the FDA’s revised guidance provides a standardized checklist for application reviewers to use to determine if the 510(k) application is complete. Preliminary questions that FDA reviewers will ask when determining the completeness of a 510(k) application include: 

  1. Is the product a device (per section 201(h) of the FD&C Act) or a combination product (per 21 CFR 3.2(e)) with a device constituent counterpart?
  2. Is the application with the appropriate Center? 
  3. Is a 510(k) the appropriate regulatory submission? 
  4. Is there a pending PMA for the same device with the same indications for use? 
  5. If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy (AIP)?

The draft guidance further provides a checklist of organizational elements that must be complied with for the 510(k) application to be accepted. A copy of the draft guidance regarding the FDA’s Refusal to Accept Policy for 510(k)s can be found here.