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Comment & Response
May 2015

Sufficiency of Information in 510(k) Summaries—Reply

Author Affiliations
  • 1National Center for Health Research, Washington, DC

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

JAMA Intern Med. 2015;175(5):864. doi:10.1001/jamainternmed.2015.84

In Reply The letter by Phillips reflects his perspectives as a former US Food and Drug Administration (FDA) regulatory official and current consultant to device companies: he expresses more concern about overtaxing FDA resources than about the lack of information available to health professionals. As public health researchers, our perspective is different: We believe that public access to scientific evidence about medical implants would improve medical outcomes.

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