Theodore T. Lee, BA; Aaron S. Kesselheim, MD, JD, MPH
Financial Support: By the Harvard Program in Therapeutic Science and the Laura and John Arnold Foundation (Dr. Kesselheim).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-2715.
Requests for Single Reprints: Aaron S. Kesselheim, MD, JD, MPH, Division of Pharmacoepidemiology & Pharmacoeconomics, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, email@example.com.
Current Author Addresses: Mr. Lee: Yale Law School, 127 Wall Street, New Haven, CT 06511.
Dr. Kesselheim: Division of Pharmacoepidemiology & Pharmacoeconomics, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
Author Contributions: Conception and design: T.T. Lee, A.S. Kesselheim.
Drafting of the article: T.T. Lee.
Critical revision of the article for important intellectual content: T.T. Lee, A.S. Kesselheim.
Final approval of the article: T.T. Lee, A.S. Kesselheim.
Obtaining of funding: A.S. Kesselheim.
In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product's widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.
Lee TT, Kesselheim AS. U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks. Ann Intern Med. 2018;168:730–732. doi: 10.7326/M17-2715
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Published: Ann Intern Med. 2018;168(10):730-732.
Published at www.annals.org on 10 April 2018
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