FDA proposes guidance on orthopedic product coatings

FDA proposes guidance on orthopedic product coatings

The US Food and Drug Administration (FDA) is seeking additional data from orthopedic device sponsors for products with metallic or calcium phosphate coatings in their premarket applications. Specifically, the agency is requesting information on coating substances, the coating process, sterility considerations, and biocompatibility in such submissions.

On January 22, the FDA issued a draft guidance outlining the required data for premarket applications for class II or class III orthopedic devices with metallic or calcium phosphate coatings. The guidance aims to assist sponsors in meeting special controls requirements for certain class II products.

The document directs sponsors to relevant consensus standards for adhering to special control requirements. FDA emphasizes that conformity to FDA-recognized versions of standards provides adequate protection for public health and safety.

While the guidance covers various coating types, it does not address certain coatings like calcium-based or ceramic coatings. Additionally, drug or biologic characterization recommendations for coated products are not included.

The guidance does not cover device-specific functional testing but advises referring to applicable device-specific guidance documents or contacting the appropriate review division for further information.

FDA requests a comprehensive description of the coating and addresses issues such as sterility, pyrogenicity, shelf-life, packaging, labeling, and clinical and non-clinical testing in premarket submissions.

Biocompatibility information is also required, reflecting its growing importance. FDA emphasizes evaluating biocompatibility for all patient-contacting materials, including coatings.

The guidance outlines scenarios requiring a new 510(k) submission for modified coating products, such as changes in coating method or vendor, coating layer alterations, or substrate material changes.

Upon finalization, the guidance will replace previous guidance on hydroxyapatite-coated orthopedic implants and metallic plasma-sprayed coatings for orthopedic implants.