FDA Looks To Expand Special 510(k) Program
US FDA released a draft guidance on the special 510(k) program in an effort to expand and improve the pathway.
You may also be interested in...
US FDA officials clarified how devices can qualify for an ongoing special 510(k) pilot program during a Nov. 8 online seminar.
Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-three new guidance documents were posted on the tracker since its last update.