Simplifying Global Compliance
MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely
Devices & Diagnostics Letter
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.
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