On May 21st the House Energy and Commerce committee unanimously passed a bill that would allow medical device companies to bypass 510(k) submissions for certain product modifications. The 21st Century Cures bill will now move to the House floor, and bill sponsors hope for a vote by the end of the year.
The device “third-party quality system assessment section” was revised by the committee and would let companies make a device modification that would typically require a 30-day notice of a “special” PMS supplement could without a submission by having their quality system specially certified by a third-party auditor.
Topics: FDA, 510(k), House of Representatives, 21st Century Cures Bill