Patient Access to Medical Devices

To the Editor: In their Perspective article, Basu and Hassenplug (Aug. 9 issue) 1 claim that the time required for patients to gain access to high-risk medical devices is roughly similar in the United States and the European Union. However, the authors do not consider in their estimates the development time required before approval. Conformité Européenne (CE) marking requires only that a device be shown to be safe and that it performs as the manufacturer had intended, not that is has clinically significant efficacy. In contrast, the U.S. premarket-approval pathway requires substantial interaction with the Food and Drug Administration (FDA) to . . .