|
MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely
An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices.
This article is viewable by subscribers only. To view this article, please select an option below.
|
|
Subscribe
Archives