FDA Initiates Pre-Cert for Software Pilot

FDA www.fda.gov is in the process of developing their new voluntary Pre-Cert for Software Pilot program. This will enable the FDA to develop a tailored approach with digital technology by looking first at the software developer not at just the product.

After doing a first review for systems for software design, validation, and maintenance, FDA will then determine whether the company meets the necessary quality standards and if so, pre-certify the company.

The companies that are pre-certified would be allowed to submit less information to FDA than is currently required before marketing a new digital health tool. Pre-certification could be used by developers for certain lower-risk devices by having the company demonstrate that the underlying software and internal processes are sufficiently reliable.

The pilot program will include up to nine software firms of various sizes. Participants range from small startups to large companies, medical product manufacturers, as well as non-traditional software developers working to develop both high and low-risk software products to include devices.

Selection for the pilot will be based on:

  • The company must be in the process of developing or planning to develop a software product that meets the definition of a medical device
  • The company must have an existing track record in developing, testing, and maintaining software products


The companies must agree to:

  • Collect real-world post-market data and provide it to FDA
  • Meet with FDA for real-time consultations
  • Be available for site visits from FDA officials
  • Provide information about the firm’s quality management system


To apply for the FDA pilot go to https://go.usa.gov/xRQCy. During August, FDA’s Digital Health Team will evaluate submissions and select companies for the pilot. FDA will hold a public workshop in January 2018 to review and report on their initial findings.

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