FDA proposes guidance on orthopedic product coatings

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On 22 January, FDA published a draft guidance on what data it wants from sponsors when they submit a premarket application for a class II or class III orthopedic device if it has a metallic or calcium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.

The document links to other guidance documents that detail consensus standards that sponsors can use when adhering to special control requirements.

“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,” said FDA. “Therefore, firms may choose to submit a declaration of conformity to the currently FDA-recognized standard.”

While the guidance details the types of coating that fall within its scope, it also notes that certain coatings, such as calcium-based coatings, ceramic coatings, and surface modifications, are not addressed in the document. The guidance also does not address drug or biologic characterization recommendations for products that are coated with a drug or biologics.

“This guidance does not address device-specific functional testing, such as system component fatigue testing,” FDA added. “For additional information on device-specific performance testing, refer to the recommendations in any applicable device-specific guidance document, if available, or contact the appropriate review division.”

As part of the proposed premarket submission recommendations, FDA said it would like a description of the coating and how sponsors have addressed issues such as sterility, pyrogenicity, shelf-life and packaging, labeling, and clinical and non-clinical testing.

FDA also wants sponsors to provide biocompatibility information, which has become an increasingly important topic in recent years. The agency has held public meetings and issued guidances on biocompatibility considerations due to the potential for some chemicals to induce a harmful biological response in patients.

“You should determine the biocompatibility of all patient-contacting materials present in your device, including both the device substrate as well as the coating,” the guidance stated. “If your coating is identical in composition and processing methods to a coating on a legally marketed device with a history of successful use, you can reference previous testing experience or literature, if appropriate.”

It added that some device materials might fulfill their biocompatibility requirements by referring to a recognized consensus standard or a letter of authorization (LOA) from a third-party master file (MAF) if the coating was applied by a third party.

The guidance also details situations where a sponsor may need to submit a new 510(k) if they’ve modified their product’s coating.

FDA said that a new 510(k) 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. However, changes such as the starting material supplier, and changing the number of coating layers while other characteristics of the coating remain the same, may not require a new application.

When the guidance is finalized, FDA said it will supersede its guidance entitled, 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants initially issued on 10 March 1995 and Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements on 2 February 2000.

Stakeholders can comment on the draft guidance on www.regulations.gov under docket no. FDA-2023-D-5430 until 22 March.

Coating orthopedic devices draft guidance

FDA proposes guidance on orthopedic product coatings

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