Responding to demands and criticism from industry and Congress to streamline device approvals, the U.S. Food and Drug Administration (FDA) issued draft guidance on July 12, 2011, proposing to exempt 30 Class I and Class II in vitro diagnostic tests and radiology devices from 510(k) premarket notification requirements. FDA also announced it will immediately stop enforcing current regulations requiring 510(k)s for those devices. Although both before and after the exemptions are formalized FDA will continue to enforce all other applicable requirements, such as registration and listing and Good Manufacturing Practices.
Noting that the safety and effectiveness of the proposed exempt devices is well-established, FDA stated that General Controls are sufficient for these devices and a 510(k) review is not necessary. FDA’s proposed exempt list includes products currently classified as Class I and II devices, 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. The guidance document listing the device types to be exempted can be found on FDA’s website.
The rulemaking process would require FDA to down-classify and exempt from 510(k) requirements the Class II devices listed in the guidance document. For the Class I devices, FDA would have to amend the classification requirements to exempt those devices from the 510(k) requirements.
Importantly, FDA also indicated in its press release that in the future it intends to reduce the premarket regulatory burden on additional in vitro diagnostic and radiology device types.
FDA is seeking further comments on the draft guidance from stakeholders. The draft guidance is open for comment for 90 days.