Dealing with the FDA today is getting slightly easier, but it is nothing to write home about. Agency plans will attempt to improve the regulatory experience; success remains to be demonstrated. Presentations by a research firm and by the Regional FDA office explored the situation at the December 9 MassMEDIC symposium referenced in the last two blog posts here.

For the first half of 2015, FDA approvals have increased markedly as compared to 2014, although the time to PMA approval remained roughly constant which suggests not so much increased speed as existence of backlog. De novo device approvals for the first six months did somewhat better; ten were granted with an average processing time of 12 months. Cardiology approvals seemed to be faster tracked for both PMAs and HDEs (humanitarian device exemption requests). 510(k) approvals for 2014 and 2015, geographically, both showed California as having the highest number, followed by Massachusetts; in 2015 so far, Florida was third, Minnesota fourth.

A rough survey of the activity of the New England FDA District (covering all six states) revealed robust investigative activity, with nine warnings issued for medical devices. Imports are growing “expotentially” with the three primary importers being (in order) Germany, Switzerland and Ireland.

Tentative FDA plans for 2016: increased training for each District office to meet growing device sophistication, and a reorganized focus on assigning reviews based on specialized substantive knowledge as opposed to assigning work merely based on geography.. This latter target is disquieting only in the sense that, presumably, the best people seemingly have not been deployed up to now where their expertise might have been best applied.