De Novo Guidance Doesn’t Cut Review Time Enough, Industry Says
This article was originally published in The Gray Sheet
Industry is skeptical of FDA claims that the plan mapped out in a recent draft guidance on de novo petitions will speed the review process for devices that aren’t a good fit for either the 510(k) or PMA programs.
You may also be interested in...
Draft User Fee Bills Aim To Streamline And Strengthen Device Regs
Details on draft legislation circulating in the House and Senate.
Shuren Defends Tentative User Fee Agreement On The Hill
Commonly paid user fees, such as the small business 510(k) submission fee, would not increase as dramatically as an overall doubling of total device user fees would suggest, argued the CDRH director, in defending a tentative FDA-industry agreement at a House hearing.
Regulatory News In Brief
Regulatory news includes new bills in the Senate, CDRH pact with LifeScience Alley and more.