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Comment & Response
May 2015

Sufficiency of Information in 510(k) Summaries

Author Affiliations
  • 1Phillips Consulting Group, LLC, Silver Spring. Maryland

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2015;175(5):863-864. doi:10.1001/jamainternmed.2015.80

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.

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