FDA proposes less stringent oversight of diagnostic, radiology devices
In an effort to reduce regulatory burden for in vitro diagnostic and radiology devices, the FDA stated its intent to exempt a number of devices from certain premarket regulatory requirements.
In a draft guidance released July 7, the FDA proposed a list of 30 different device types—including urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories—for which less stringent oversight would not compromise public health.
The devices are set to be downgraded from 510(k) requirements because the FDA “believes the safety and effectiveness of these devices is sufficiently well established and they have sufficiently controlled risks,” the guidance states. “A 510(k) review is not necessary to assure the safety and effectiveness of such devices.”
While these devices are not yet exempt, the FDA stated that it does not intend to enforce premarket notification requirements with respect to these devices, provided that they do not exceed the limitation 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, MD, 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 devices.”
The administration stated it will continue to enforce registration, listing and labeling good manufacturing practice requirements and medical device reporting requirements, as part of the Food, Drug and Cosmetics Act.
A full list of the proposed devices can be found here. The FDA is seeking input on the draft guidance from manufacturing, clinical and patient communities, and a comment period is open for 90 days. Additional in vitro diagnostic and radiology device types may be subject to less stringent oversight in the future, according to the administration.
In a draft guidance released July 7, the FDA proposed a list of 30 different device types—including urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories—for which less stringent oversight would not compromise public health.
The devices are set to be downgraded from 510(k) requirements because the FDA “believes the safety and effectiveness of these devices is sufficiently well established and they have sufficiently controlled risks,” the guidance states. “A 510(k) review is not necessary to assure the safety and effectiveness of such devices.”
While these devices are not yet exempt, the FDA stated that it does not intend to enforce premarket notification requirements with respect to these devices, provided that they do not exceed the limitation 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, MD, 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 devices.”
The administration stated it will continue to enforce registration, listing and labeling good manufacturing practice requirements and medical device reporting requirements, as part of the Food, Drug and Cosmetics Act.
A full list of the proposed devices can be found here. The FDA is seeking input on the draft guidance from manufacturing, clinical and patient communities, and a comment period is open for 90 days. Additional in vitro diagnostic and radiology device types may be subject to less stringent oversight in the future, according to the administration.