Drugs, Devices, and FDA

To ensure that medical treatments reach patients in a timely manner, the AAOS closely follows Food and Drug Administration (FDA) regulatory and legislative developments and provides appropriate responses to proposed rules, guidance documents, and legislative initiatives. AAOS supports the approval and clearance of safe and effective medical products for musculoskeletal care. Additionally, with appropriate data, 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 launched a pain alleviation 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.

Position Statements

Important Resources

Comment/Congressional Letters

Other Materials