Orthopedic Implant Classification Scheme Proposed To HHS Secretary’s Panel
This article was originally published in The Gray Sheet
FDA's medical device classification system should include a separate category for non-life-threatening implants such as prostheses, according to the American Academy of Orthopaedic Surgeons
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KNEE, SHOULDER IMPLANT DOWNCLASSIFICATION PETITIONS are under development by a coalition of orthopedics groups including the American Academy of Orthopedic Surgeons, the American Orthopedic Association, the American Society for Testing and Materials, the Orthopedic Surgical Manufacturers Association and the Orthopedic Research Society. Informally known as the "Device Forum," the group hopes to present preliminary drafts of the petitions -- which will seek to move certain knee and shoulder implants from Class III to Class II -- to the FDA Office of Device Evaluation's Orthopedic Devices Branch at the end of April.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.