The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more
On July 3, 2023, Senators Bernie Sanders (I-Vt.), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Bill Cassidy, M.D. (R-La.), Ranking Member of the HELP Committee, Bob Casey (D-Pa.), and Mitt...more