The Institute of Medicine is scheduled to release the report on Friday. The FDA commissioned the report after several high profile recalls of devices that failed in thousands of patients, causing numerous injuries.
However, the Washington Legal Foundation, a pro-business group, has filed a petition arguing that the FDA is legally barred from adopting the report’s recommendations because the IOM panel making the report failed to include representatives from the device industry and investors.
Read the New York Times report on concerns about an upcoming report on FDA device oversight.
Related Articles on FDA Device Oversight:
Journal Editors Blast Studies Used by Critics of FDA Device Process
House Committee Chair Accuses FDA of Overregulating Devices
Devicemakers Ask Congress to Ease Regulatory Burdens on Industry
