The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a metallic or calcium phosphate coating. Specifically, the agency wants data on substances used for coating, the coating process, sterility considerations, and biocompatibility considerations in such submissions.
On 22 January, FDA published a draft guidance on what data it wants from sponsors when they submit a premarket application for a class II or class III orthopedic device if it has a metallic or calcium phosphate coating. The agency also states that some of its recommendations may help sponsors comply with special controls requirements for certain class II products…
