HOUSE FDA REFORM BILL'S "SCOPE OF REVIEW," THIRD-PARTY PROVISIONS COULD BE CHANGED BEFORE SEPT. 25 COMMITTEE MARK-UP; HEALTH SUBCMTE. CLEARS BILL SEPT. 17
This article was originally published in The Gray Sheet
Executive Summary
Provisions in the House FDA device reform bill (HR 1710) limiting FDA 510(k) review authority to claims made in labeling and codifying a third-party review program could be modified to address Democratic concerns before Commerce Committee mark-up of the bill on Sept. 25.