The FDA has issued a draft guidance that shows it may relax premarket notification requirements for certain in vitro diagnostic and radiology devices.
The draft lists 30 device types, including common urine and blood tests, alcohol breath tests, blood clotting protein tests and such radiology device accessories as film cassettes, film processors and digitizers. The agency hopes to exempt these devices from premarket notification requirements through the appropriate regulatory processes. In the meantime, the FDA doesn't intend to enforce the premarket notification requirements with respect to these devices "provided that they do not exceed the limitations on exemption specified in the device classification regulations."
"The safety and effectiveness of these devices have been well demonstrated over the years," said Jeffrey Shuren, director of CDRH, in a statement. "By addressing the risk level of these devices, the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers, while making sure the public has safe and effective devices."
The FDA is seeking further comment on the draft guidance from manufacturing, clinical and patient communities. The draft guidance is open for comment for 90 days. The agency adds that it hopes intends to reduce the premarket regulatory burden on additional in vitro diagnostic and radiology device types in the future.
- see the FDA's release