More Medical Device Hearings in Congress Scheduled for This Week

Apr 12, 2011   

Hearings in both the House and the Senate will take place this week to discuss the U.S. Food and Drug Administrations (FDA) medical device approval and clearance processes. The purpose of these hearings will be to examine how the medical device industry interacts and communicates with the FDA medical device regulators.

On April 13, the Senate Special Committee on Aging will hear “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process.” At this time, no agenda or witness list has been provided.

The House Oversight and Government Reform Subcommittee on Health Care will hold a hearing entitled “Pathway to FDA Medical Device Approval: Is There a Better Way?” on April 14. Dr. Jeffery Shuren, the director for the FDAs Center for Devices and Radiological Health (CDRH) will be one witness at this hearing.

These two hearings will be the second round to take place over the last two months examining FDAs medical device approval and clearance processes and proposed medical device process reform.