FDA releases draft guidance for patient-matched guides to orthopedic implants
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Key takeaways:
- The FDA released a draft guidance for regulatory submissions of patient-matched guides to orthopedic implants.
- The guidance also included recommendations for manufacturers in the device design process.
The FDA released a draft guidance for information that should be included in regulatory submissions of patient-matched guides to orthopedic implants, according to a draft guidance document.
In addition, the draft guidance includes design recommendations for device manufacturers.
“This guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides,” members of the FDA wrote in the draft guidance.
The FDA guidance includes recommendations on indications for use, device description, software, biocompatibility, sterility, shelf life and packaging, nonclinical performance testing and clinical performance testing.
“Following such recommendations may increase efficiency and consistency in review,” members of the FDA wrote.
Comments on the draft guidance should be submitted online or in writing by Aug. 28.
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