UVC Safety and Compliance for OEMs

New UVC Photobiomodulation Medical devices in contact with the body or under development for specific new phototherapy treatments would require additional FDA approvals. These UVC medical devices will typically require a series of clinical trial to prove efficacy and safety (minimal harmful side effects).  When a predicate device exists, manufacturers can obtain clearance via the 510(k) premarket notification process and are not required to run new clinical trials. the FDA accepts non‑clinical performance testing to show the device is substantially equivalent to an existing product.

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