Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned From the Parallel Review Pathway

Abstract

Background: The US Food and Drug and Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) both play key roles in evaluating new medical devices. In 2011, they jointly launched the Parallel Review Pathway as a means for manufacturers of high-risk medical devices to meet the review requirements of FDA and CMS simultaneously. Through this model, CMS undertakes evaluation for a national coverage determination in conjunction with the submission of clinical trial and other data to the FDA for its review, rather than the traditional timing after FDA approval. The purpose of this article is to review the initial promise of the parallel review pathway and consider explanations for its unmet expectations. Methods: We review the underlying support for parallel review, characterize its outcomes to date, and consider reasons why its utilization has not met expectations. We highlight examples of supporting evidence used to We propose solutions for increasing participation in parallel review as a means towards increasing regulatory efficiency alongside strengthening evidence of safety and effectiveness among Medicare beneficiaries. Results: Despite a strong theoretical grounding, only 3 devices have completed parallel review, with a 4th under evaluation. Two devices received joint approval from CMS and FDA, while one device was rejected by the FDA for lack of clinical evidence demonstrating efficacy when compared to control. Conclusions: This analysis reveals shortcomings of parallel FDA and CMS review for medical devices and provides important lessons for understanding manufacturers’ incentives, risk tolerance, and the remaining barriers for streamlining device review while preserving high standards that protect public health.