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US FDA released a draft guidance on the special 510(k) program in an effort to expand and improve the pathway.
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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.
Global Medtech Guidance Tracker: September 2018
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.