FDA Guidance Provides Detail on Submission of 3D Printed Orthopedic Implants

A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant systems such as knee or hip replacements.

The design process must be included in the device description, along with intended surgical use, as these are necessary to support a regulatory submission, the 21-page draft guidance, “Patient-Matched Guides to Orthopedic Implants” says.

The draft guidance provides details on numerous elements for a regulatory submission, including indications for use, patient-matched guide description, and “image processing methods to illustrate how the patient image(s) is received and manipulated prior to pre-operative planning” as well as recommendation on communications between the healthcare provider and the manufacturer and compatible surgical techniques.

Comments are due by Aug. 28.

Read the guidance here.

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