How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Abstract

Background The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and

Transparency and Dermatologic Device Approval by the US Food and Drug Administration

“…Orthopedic and cardiac devices share similar trends for modifications through the 180-day process, while otolaryngology device manufacturers have a tendency to use the special-track approval for changes in indication. 2,7,8 Although applications are reviewed on a case-by-case basis, supplement pathways may allow for inadequately supported changes in product design or indications.…”

Policy and ethical considerations for widespread utilization of generic orthopedic implants

“…They further describe that implant devices that retrospectively were required to undergo the PMA process were often modified many times through PMA supplement pathway without clinical data to support the safety of design changes. A relevant finding of their study was that most FDA recalls of PMA devices were not secondary to design flaw but instead a result of issues with processing, packaging, or labeling [29] . These findings support the further expansion of efforts to build national and international orthopedic device registries—with special attention given to the monitoring of generic implants.…”

Generating evidence for new high-risk medical devices

“…These challenges are especially difficult for small companies and developers. Trials are vexed by learning curves and rapid iterations of device design, adding to the difficulties of choosing appropriate comparators and outcomes 2 8 9. Speed of evidence generation matters because it is a costly process.…”