Can you sell a medical device without FDA approval?
A medical device may legally be sold without FDA “approval” when it is 510(k)-cleared, De Novo-authorized, or properly exempt from premarket submission. It cannot lawfully be marketed when required authorization is missing or when its labeling creates an unreviewed intended use.
Answer
Whether a medical device can be sold without FDA approval depends on what “approval” means. Only devices reviewed through the PMA pathway are formally FDA-approved. Many legally marketed devices are instead 510(k)-cleared, De Novo-authorized, or exempt from a premarket submission.
A device may generally enter U.S. commercial distribution when:
• It is exempt from 510(k) or PMA requirements and complies with applicable controls
• FDA has issued the required 510(k) clearance
• FDA has granted a De Novo request
• FDA has approved the applicable PMA, HDE, or supplement
• Another lawful mechanism, such as an Emergency Use Authorization, applies
Registration and device listing alone do not create permission to sell. A product can appear in FDA’s registration database while still lacking required premarket authorization. Companies must not present registration as evidence that a device is “FDA approved.”
A device may become adulterated or misbranded if it is sold without required authorization, manufactured outside applicable quality-system requirements, labeled misleadingly, or promoted for an unapproved intended use. Significant changes to a cleared device’s design, technology, indications, or labeling may also trigger a new 510(k) or another submission.
Manufacturers and importers should confirm the product code, classification, exemption limitations, applicable submission, manufacturing controls, labeling, and listing status before commercial distribution.
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