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To the Editor In their report on the lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices, Zuckerman and colleagues1 create a misleading impression of the evaluation of class II implants by the US Food and Drug Administration (FDA). Although the data are accurate, an understanding of the intricacies of device regulation is required to judge the agency’s performance.
Phillips PJ. Sufficiency of Information in 510(k) Summaries. JAMA Intern Med. 2015;175(5):863-864. doi:10.1001/jamainternmed.2015.80