Medical Devices

Digital Health Software Precertification (PreCert) Program

Digital health technology has become a new health care revolution that empowers consumers to make better-informed decisions about their health. At the FDA, we recognize this revolution and are reimagining our oversight of digital health technology to help provide patients with timely access to high-quality, safe, and effective digital health products.

We’ve provided details and timelines for our digital health efforts in our Digital Health Innovation Action Plan, and one important piece of this plan is a new pilot program for software developers named the "Software Precertification (PreCert) Pilot Program." FDA’s traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the faster and iterative design, development, and validation used for software products. The Software PreCert Pilot Program is a voluntary program that will enable us to develop a tailored approach toward regulating this technology by looking first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for more traditional medical devices. This pilot will help FDA establish the most appropriate criteria for standing up a firm-based precertification program for these new tools.

The goals of this program are to:

  • enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;
  • ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and
  • be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

For more information on how to participate in the pilot, please view the FR notice or email FDAPre-CertPilot@fda.hhs.gov.

Page Last Updated: 08/08/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English