The US Food and Drug Administration (FDA) has published a final order that exempts many Class I and Class II medical devices from 510(k) premarket review with effect from 6 January 2020. The final order decreases regulatory burden on medical device manufacturers and eliminates costs associated with complying with those rules, the agency said.
Devices on the list range from clinical chemistry and toxicology to certain cardiovascular, dental, hearing, neurological, orthopedic and radiology devices, drawn from 16 broad categories, under authority from the 2016 ’21st Century Cures Act’. This Act requires FDA to identify low-risk devices that it determines no longer require a 510(k) review in order to provide a reasonable assurance of safety and effectiveness.
Devices newly exempted from 510(k) review under the final order are still subject to other regulatory controls, such as good manufacturing practice requirements, however.