Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance

Devicemakers praised FDA efforts to craft guidance on the agency’s refuse-to-accept policy for 510(k) premarket notification submissions, but took issue with many specifics, including what would happen if a backlog causes the FDA to miss its proposed 15-day timeline.

AdvaMed recommended the FDA modify the draft to ensure it asks that acceptance reviewers only look to see whether documents are present, rather than attempting to answer the more in-depth question of adequacy.

AdvaMed also asked the FDA to clarify whether failure to submit electronically would result in a submission’s rejection and to remove references to advertisements from the reviewer checklist.
If you’re a mobile app developer, does the 510(k) process even concern you? What office at the FDA do you even go to when you have questions?

If you didn’t know, a California congressman has announced plans to introduce a bill requiring the FDA to establish an Office of Mobile Health to help speed the development and approval of device apps.

The mobile app market is booming, and so many apps can be considered a medical device that would be regulated by the FDA … and you wouldn’t know.

Be sure to attend FDAnews’ rebroadcast of Medical Device Mobile Apps: What Needs FDA Approval.

Attendees will come away with ideas on how to transform their traditional devices into apps, a better understanding of what needs FDA approval and lessons learned from a firm that already has an FDA-approved app on the market. Register for this Oct. 31 webinar today.