New High-Tech Coatings Not Fully Addressed in Draft Guidance, Commenter Says

New draft guidance for ceramic and metal coatings on implantable orthopedic devices needs to recognize the different bonding characteristics of a new generation of extremely thin, nonporous metallic coatings applied by ion beam deposition, according to one of seven comments filed on the document.

The draft guidance, “Characterization of Metallic 2 Coatings and/or Calcium Phosphate 3 Coatings on Orthopedic Devices,” addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate or a combination of those materials.

The draft guidance updates a 24-year-old guidance that focused on plasma-sprayed coatings, which are extremely thick and have large interconnected pores extending throughout the coating. The highly porous structure of the older coatings increases surface area, which helps the coating pass adhesive bonding tests and incorporates requirements for such adhesive bonding tests from the 2000 guidance.

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