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

Ann Intern Med. 2018 May 15;168(10):730-732. doi: 10.7326/M17-2715. Epub 2018 Apr 10.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Certification*
  • Humans
  • Medical Informatics Applications*
  • Pilot Projects
  • Product Surveillance, Postmarketing
  • Program Development
  • Risk Assessment
  • Software / classification*
  • Software Validation*
  • United States
  • United States Food and Drug Administration*