Changes to FDA Classification of Certain Medical Products
This act changes how certain medical products, like contrast agents or eye drops with dispensers, are classified by the U.S. Food and Drug Administration (FDA). Instead of being treated as 'devices', they will now be legally considered 'drugs'. This means they will be subject to different rules for approval and oversight, potentially affecting their availability and information provided to patients.
Key points
Certain medical products, including contrast agents and eye drops with dispensers, will now be legally classified as drugs instead of devices.
This change in classification means these products will be subject to different FDA rules for approval and regulation.
The new rules apply to both future and some current applications for these products.
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