Orthopaedic surgical devices are recalled 11.5 times more when they obtain U.S. Food and Drug Administration (“FDA”) clearance by Premarket Notification (“510(k)”) than when they are cleared via the more vigorous Pre-market Approval (“PMA”) review. Recall of implanted orthopaedic devices can be devastating for patients – especially if the device must be removed or revised. 510(k) approval is also associated with other negative outcome issues among orthopaedic devices – including outlier devices, new devices underperforming their predicate ancestors, and significant statistical risks – which are discussed in this paper. In November 2018, the FDA announced changes to 510(k) including: (1) increasing premarket expectations for device submissions, (2) implementing a “Refuse-to-Accept” policy for incomplete applications, (3) improving the consistency and thoroughness of device review, (4) eliminating the use of 510(k) for devices considered to be of higher risk (i.e., Class III devices), and (5) eliminating over 1000 devices as 510(k) legal predicates. This article (1) explores the recent changes to 510(k) outlined by the FDA in 2018, (2) evaluates their likely effects on the outcomes of orthopaedic devices, and (3) proposes solutions to improve those outcomes, including FDA regulatory changes, litigation changes with regard to informed consent and Daubert rulings, and Congressional actions to hold device manufacturers more accountable based upon models currently in place affecting hospitals, doctors, and nursing homes.
Safety and Efficacy of Orthopaedic Surgical Devices Under the FDA’s Updated Premarket Notification Program,
84 Mo. L. Rev.
Available at: https://scholarship.law.missouri.edu/mlr/vol84/iss3/8