Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 03/13/2023 updates the reason for alert and guidance section. Changes to the import alert are bracketed by asterisks (***). Devices listed on the Red List of this alert ***are either devices or which a 510(k) application has not been filled and/or determined substantially equivalent, Class III medical device for which there is no Pre-Market Approval (PMA) for commercial distribution, or investigational device that lacks an Investigational Device Exemption (IDE).***

Quoted from the “Reason for Alert” section of the FDA page for 89-08, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.