FDA Premarket Requirements for Ortho Device Coatings Draft Guidance Issued

The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of those materials.

The 25-page guidance, “Characterization of Metallic 2 Coatings and/or Calcium Phosphate 3 Coatings on Orthopedic Devices,” also includes recommendations on sterilization, shelf life and packaging, biocompatibility with human tissues, non-clinical bench testing, animal and human studies and labeling. The document provides the first update for hydroxyapatite-coated devices since 1995, and the first for metallic-coated devices since 2000.

The document advises that in general, premarket submissions should contain specific details about the coating’s physical characteristics, where it was manufactured and how it was applied.

The comment period is open until March 25.

Read the draft guidance here.

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