FDA Denies Request to Expand PMA Revocation Authority

The FDA has turned down a request to expand the criteria it uses when revoking a PMA. The Public Citizen’s Health Research Group had sent a petition nearly six years ago asking the FDA to write a new regulation that enables the agency to withdraw approval for a device that has caused patients harm in cases where another marketed device is equally effective for the same use, but poses less risk.
Devices & Diagnostics Letter