SILVER SPRING, Md., July 7, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration issued a draft guidance today
describing its intent to exercise enforcement discretion with
respect to the premarket notification requirements for certain in
vitro diagnostic and radiology devices with well-established
safety and effectiveness profiles.
The draft guidance lists 30 different device types, including
common urine and blood tests, alcohol breath tests, blood clotting
protein tests, and radiology device accessories, such as film
cassettes, film processors, and digitizers. FDA intends to
exempt these devices from premarket notification requirements
through the appropriate regulatory processes. In the
meantime, however, FDA does not 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.
FDA intends to continue to enforce all other applicable
requirements, including, but not limited to, registration and
listing and Good Manufacturing Practices as set forth in the
Quality System regulations.
“The safety and effectiveness of these devices have been well
demonstrated over the years,” said Jeffrey Shuren, M.D., director
of FDA’s Center for Devices and Radiological Health. “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
The device types listed in the draft guidance include devices
identified by the FDA as those for which less stringent oversight
would not compromise public health.
The FDA is seeking further comment on the draft guidance from
manufacturing, clinical and p