FDA Sets Meeting on Medical Device Innovation Initiative
The March 15 meeting in Silver Spring, Md., is part on a planned strengthening of the Center for Devices and Radiological Health’s 510(k) premarket notification process, which is currently used to clear new AEDs for the marketplace.
FDA announced it will hold a meeting March 15 in Silver Spring, Md., about its Medical Device Innovation Initiative. The event will be useful to medical device manufacturers include automated external defibrillators; FDA has an initiative in place to encourage manufacturers to develop more reliable AEDs, and an FDA Circulatory System Devices advisory committee met last month to discuss whether AEDs should be regulated more stringently by the agency.
New AEDs are cleared to be marketed using the FDA’s 510(k) premarket notification process, but the question is whether they should be subjected to the more stringent premarket review given to other class III devices – as recommended by staff from FDA’s Center for Devices and Radiological Health. The committee met Jan. 25 to consider which method to recommend. 510(k) is a section of the Food, Drug and Cosmetic Act.
The meeting will be available as a live webcast at http://fda.yorkcast.com/webcast/Viewer/?peid=fae7c7ac49174d159e49e8d83aaf3b9d. Anyone interested in attending the meeting is asked to register by 5 p.m. March 4 at this site.