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FDA floats updated orthopedic coatings guidance
"Stay updated on FDA s proposed guidance for orthopedic product coatings. Learn about additional data requirements and potential changes to 510(k) submissions."
Draft guidance
Remarket application requirements
Rthopedic product coatings
Regulatory focus
Alcium phosphate coating
Coating process
Terility considerations
Iocompatibility considerations
Special control
Consensus standards
Da recognized version
Public health
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