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Premarket Approval Supplement Pathway: Do We Know What We Are Getting?Premarket Approval Supplement Pathway

Sarah Y. Zheng, AB; and Rita F. Redberg, MD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 25 March 2014.

From University of California, San Francisco, San Francisco, California.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2931.

Requests for Single Reprints: Rita F. Redberg, MD, University of California, San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143-0124.

Current Author Addresses: Ms. Zheng and Dr. Redberg: University of California, San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143-0124.

Author Contributions: Conception and design: S.Y. Zheng, R.F. Redberg.

Analysis and interpretation of the data: S.Y. Zheng.

Drafting of the article: S.Y. Zheng.

Critical revision of the article for important intellectual content: R.F. Redberg.

Final approval of the article: R.F. Redberg.

Administrative, technical, or logistic support: R.F. Redberg.

Collection and assembly of data: S.Y. Zheng, R.F. Redberg.

Ann Intern Med. 2014;160(11):798-799. doi:10.7326/M13-2931
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The U.S. Food and Drug Administration assesses the safety and effectiveness of new high-risk medical devices through a process known as “premarket approval” (PMA), whereas modifications of existing devices may be approved by a less rigorous procedure known as “PMA supplement.” This commentary discusses safety concerns for this alternate pathway and its implications for clinicians and policymakers.

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