Red Tape Reduction: FDA Issues List of 510(k) Device Exemptions

January 3, 2020

On December 30, the FDA issued a notice (see the FDA’s Federal Register notice)  that exempts certain class I and II medical devices from 510(k) premarket notification requirements. The exemptions, some of which are limited, cover a wide range of different products, including clinical chemistry test systems, clinical laboratory instruments, clinical toxicology test systems, hematology and pathology devices, immunology and microbiology devices, cardiovascular devices, orthopedic devices, ophthalmic devices, and radiology devices, amongst others. The FDA believes that the action “decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.”

The exemptions’ list has been under review by the FDA for some time following enactment of the 21st Century Cures Act (Cures Act)  in 2016. The Cures Act, in part, required the FDA to identify class I and II devices that the agency determines no longer require a premarket notification 510(k) report to provide reasonable assurance of safety and effectiveness. The FDA is required to publish a list of exemptions at least every five years.

According to the notice, exempt devices are still subject to other statutory and regulatory requirements to protect patient safety, such as good manufacturing practice requirements. The exemptions took effect December 30.