Drugs, Devices, and FDA

For several decades, the American Association of Orthopaedic Surgeons (AAOS) has interacted with the Food and Drug Administration (FDA). To ensure that medical treatments reach patients in a timely manner, the AAOS closely follows FDA regulatory and legislative developments and provides appropriate responses to proposed rules, guidance documents, and legislative initiatives. The AAOS supports the approval and clearance of safe and effective medical products for musculoskeletal care. Additionally, with appropriate data, the AAOS encourages the downclassification of devices whose risk/benefit profile can be managed with the FDA's use of general and special controls, including the use of guidance documents and consensus standards.

Also note, to help prepare our members for conversations with their patients, AAOS recently launched a new pain relief tool kit. The online resource includes pre- and postoperative discussion talking points on pain relief, common pain relief solutions, orthopaedic and emergency department opioid strategies, a questionnaire for determining patient opioid addiction risk, and safe use storage and disposal strategies/resources.

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