FDA Proposes Alternatives to Submitting Biocompatibility Data for Devices Using Common Polymers, Fabrics

Dennis Tosh
October 15, 2020 at 09:39 AM EST
The FDA Oct. 14 released draft guidance that proposes select updates to the agency’s current policy on the type of biocompatibility information that should be provided to the agency in premarket submissions for medical devices made from common polymers and fabrics that come in contact with intact skin. In an Oct. 15 Federal Register notice announcing the availability of the d... Read More

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