The U.S. Food and Drug Administration (FDA) has issued draft guidance for premarket submissions for orthopedic devices with certain coatings.
In the draft guidance, the FDA provides “recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface.” Specifically, the guidance applies to class II and class III devices intended for orthopedic applications that contain “metallic coatings, calcium phosphate coatings, or metallic and calcium phosphate dual coatings.”
The FDA recommends that the following information be included with submissions:
- coating description,
- sterility,
- pyrogenicity,
- shelf life and packaging,
- biocompatibility,
- non-clinical bench testing,
- non-clinical animal testing,
- clinical performance testing, and
- labeling.
The coating description should include:
- the name of the coating,
- coating method,
- starting materials,
- physical structure of the coating,
- the location of the coating and
- its coverage of the device.
The agency also recommended that manufacturers sterilize all coated orthopedic devices and if a coated device is provided non-sterile additional justification should be provided. In addition, the agency recommended that coated orthopedic devices meet applicable pyrogen limit specifications to address certain associated risks. Additional details regarding the information that is being recommended can be found in the draft guidance.
The draft guidance does not apply to other types of coatings such as other calcium-based coatings and other ceramic coatings. The guidance also does not apply to surface modifications such as surface etching and surface anodizing.
Under the draft guidance, sponsors may also be required to submit a new 510(k). This would be required if certain changes or modifications are made to the coating method, coating vendor, coating layer, another substrate material, or the surface treatment.
Draft guidance, when finalized, represents the current thinking of the FDA. It does not establish rights and is not binding. Once finalized, the guidance will supersede the 1995 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants and 2000 Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements.
The deadline to submit comments is March 22, 2024.
