FDA proposes first update to orthopedic device coating guidance since 1990s

The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types. The guidance appears to be explaining current review processes, rather than updating the agency’s existing policies; once finalized it would supersede a guidance from 1995.

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