A pair of hearings on Capitol Hill this week aim to peer closely at how the medical device industry interacts with regulators at the FDA.
The higher chamber kicks things off April 13 with the Senate Special Committee on Aging’s hear, “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process.” No agenda or witness list has been released about the nature of the hearing.
The House Oversight & Government Reform Subcommittee on Health Care is scheduled to hold its “Pathway to FDA Medical Device Approval: Is there a Better Way?” hearing April 14, to “study the FDA’s inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”
The GOP-led committee said it will call Rep. Erik Paulsen (R-Minn.) and CDRH chief Dr. Jeffrey Shuren as witnesses. The committee will also hear from Jack Lasersohn, a general partner at The Vertical Group, and David Gollaher, president and CEO of the California Healthcare Institute. The committee is chaired by Rep. Trey Gowdy (R-S.C.).
The hearings will be the second round in the last two months to look at how the medical device industry interacts with the Food & Drug Administration, which is proposing several changes to the 510(k) pre-market clearance program.