US Regulators to Exempt Some Class I and II Medical Devices from 510(k) Premarket Review
The US Food and Drug Administration plans to exempt certain medical devices from 510(k) premarket notification requirements due to what the agency considers their well-established safety and effectiveness.
For the time being, the FDA will no longer enforce 510(k) compliance for devices listed in its draft guidance. The agency plans to issue a final rule that will formally exempt those devices from premarket notification requirements.
It must be emphasized that manufacturers of Class I and II devices qualifying for 510(k) exemption will still have to comply with requirements such as registration and labeling, FDA Good Manufacturing Practices and incident reporting.
Several device categories are targeted for 510(k) exemption by the guidance, including anesthesiology, cardiovascular, dental and ophthalmic devices. A full list of qualifying devices is available in the guidance document.