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US Pre-Clearance Inspections Imminent For Devices Sterilized By Novel Techniques

This article was originally published in Clinica

Executive Summary

Sponsors of sterile medical devices who use novel techniques to sterilize their products - such as, vaporized peracetic acid, high intensity light, microwave radiation, sound waves and ultraviolet light - will soon be subject to mandatory manufacturing site inspection by the US FDA before their pre-market notification, or 510(k), submission can be cleared.

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