FDA issues guidance on exempting certain medical devices from 510(k) requirements

USA: The US Food & Drug Administration (FDA) has issued guidance describing the intent to exempt certain unclassified medical devices from 510(k) submission. The devices exempted from this premarket notification requirement will be those that the FDA believes are sufficiently well understood and do not require 510(k) to assure safety and effectiveness.

Medical devices that are exempt from 510(k) will still be required to comply with other statutory and regulatory requirements, including but not limited to registration and listing, labeling, good manufacturing practice requirements and Medical Device Reporting requirements.

The full guidance can be found here: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements

Please do contact us if you have any questions about the new guidance, or need help identifying which devices require 510(k), and which are exempt.