FDA Issues Proposed Rule for De Novo Classification Process That Would Establish Submission Requirements
December 5, 2018 at 11:17 PM EST
A proposed rule on the FDA’s de novo classification pathway to market for medical devices, issued Dec. 4, would establish requirements for the submission of de novo requests and codify procedures for agency review of and decisions on those requests. The proposal was published in the Federal Register Dec. 7 (83 Fed. Reg. 63127).
The FDA’s move comes just over a week after the ... Read More
