Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance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.
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.
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!