Update regarding opportunities for orthopaedic surgeons to contribute to postmarket surveillance of potential safety issues for orthopaedic medical devices marketed in the United States

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health [1]. Through consideration of benefit-risk principles for the evaluation of medical devices, CDRH decisions seek an appropriate balance between protection of the US public and encouragement of innovation directed toward improvement in health outcomes [2,3]. Within the regulatory framework established for medical devices by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, CDRH evaluates the safety and effectiveness of medical devices according to a risk-based paradigm. Risk is assessed as the potential for a device to present harm to the patient, including circumstances inwhich the device could malfunction or be used improperly under anticipated conditions of use. Medical device product evaluation presents unique challenges compared to drugs and biologics. These challenges relate to the great diversity and complexity of medical devices, the rapid pace of technological innovation, and iterative nature of medical product device development [4]. Following approval or clearance of a medical device for the US market, residual uncertainty regarding