Mark Leahey, president of the Medical Device Manufacturing Assocation, said there is likely to be more testimony on Capitol Hill over the FDA, including the medical device approval process and the Medical Device User Fee and Modernization Act.
Mr. Leahey added the media “overstated” criticisms of the 510(k) medical device approval process but expressed concern that the agency failed to institute seven of 10 Institute of Medicine recommendations for the 510(k) process, according to the news report.
Read the news report about the FDA and its 510(k) process.
Read other coverage about the FDA:
– FDA Approves Enhanced Flow Meter Visualization From OSI Systems
– FDA Defends Actions Regarding Triad Sterile Lubricating Jelly
– FDA Bans Marketing of Unapproved Drugs to Protect Providers, Patients
