The FDA published a draft guidance of updated premarket application requirements for orthopedic product coatings, according to a Jan. 22 report from the Regulatory Focus.
The FDA is recommending orthopedic device sponsors provide additional data in their application if their product contains metallic or calcium phosphate coating. The agency plans to request data on the coating process, sterility considerations and biocompatibility considerations in such submissions.
"Where consensus standards are included in a special control for devices within the scope of this guidance, FDA believes conformance to the currently FDA-recognized version of the standard would provide the same level of or improved protection of the public health and safety as conformance to other versions of these standards included in a special control, and that conformance to the currently FDA-recognized standard would meet any such consensus standards included in a special control," the FDA wrote. "Therefore, firms may choose to submit a declaration of conformity to the currently FDA-recognized standard."
The guidance does not address calcium-based coatings, ceramic coatings and surface modifications or drug or biologic characterization recommendations for products that are coated with a drug or biologics.
The FDA would require a description of the coating and how sponsors have addressed issues including sterility, pyrogenicity, shelf-life and packaging, labeling and clinical and nonclinical testing.
The guidance also states that the agency may require sponsors to submit a new 510(k) if they modify their product's coatings. A new application may be required in instances where the manufacturer has changed the coating method, the coating vendor, made changes to the coating layer, or made changes to the substrate material.
If the new guidance is finalized, it would supersede coated orthopedic implant guidelines from 1995 and 2000. Stakeholders can issue comments on draft guidance until March 22.