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U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.

PMID: 29632953 · 2018-04-10

T, h, e, o, d, o, r, e, , T, , L, e, e, ;, , A, a, r, o, n, , S, , K, e, s, s, e, l, h, e, i, m

학술지Annals of internal medicine

연도2018-04-10

PMID29632953

초록

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 incentiv

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