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Breakthrough Medical Devices and the 21st Century Cures ActBreakthrough Medical Devices and the 21st Century Cures Act

Aaron S. Kesselheim, MD, JD, MPH; and Thomas J. Hwang, AB
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 19 January 2016.


From Brigham and Women's Hospital and Harvard Medical School and Bain Capital Ventures, Boston, Massachusetts.

Disclaimer: The views expressed in this article are solely those of the authors.

Acknowledgment: The authors thank Ameet Sarpatwari, JD, PhD, for his comments on an earlier draft.

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1906.

Requests for Single Reprints: Aaron S. Kesselheim, MD, JD, MPH, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, akesselheim@partners.org.

Current Author Addresses: Dr. Kesselheim: Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120.

Mr. Hwang: Bain Capital Ventures, 200 Clarendon Street, Boston, MA 02116.

Author Contributions: Conception and design: A.S. Kesselheim, T.J. Hwang.

Analysis and interpretation of the data: T.J. Hwang.

Drafting of the article: A.S. Kesselheim, T.J. Hwang.

Critical revision of the article for important intellectual content: A.S. Kesselheim, T.J. Hwang.

Final approval of the article: A.S. Kesselheim, T.J. Hwang.

Provision of study materials or patients: T.J. Hwang.

Collection and assembly of data: T.J. Hwang.


Ann Intern Med. 2016;164(7):500-502. doi:10.7326/M15-1906
© 2016 American College of Physicians
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In 2012, Congress gave the U.S. Food and Drug Administration (FDA) authority to designate new drugs with promise of substantial benefit as “breakthrough” drugs and then take steps to expedite their pathway to possible approval. Congress is now deciding whether to grant the FDA the authority to give medical devices the same designation. This article examines the risks, benefits, and ethical considerations of that decision.

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