March 13, 2019

ACR Recommends Changes to FDA Software Pre-Cert 1.0 Pilot Program

On March 8, 2019, the American College of Radiology (ACR) submitted comments to the U.S. Food and Drug Administration (FDA) regarding the Software Precertification Program (Pre-Cert) Working Model Version 1.0. The ACR’s comments reemphasized key points from a May 2018 comment letter on an earlier version of the pilot program’s framework.

The FDA’s Pre-Cert program, currently in an extended pilot phase, is intended to take an organization-level approach to evaluating the safety and effectiveness of Software as a Medical Device (SaMD) or “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

The concept is similar to TSA Pre-Check®. By demonstrating certain principles of excellence, companies can be pre-certified to use expedited FDA pathways for getting their SaMD and major updates to market. SaMD in the program are subject to real world performance monitoring.

The ACR expressed concern that participation in the pilot phase has thus far been limited to a few moderate- to large-sized medical device and consumer technology companies that possess extensive resources.

The College recommended that the FDA proactively involve small developers and eliminate the discrepancies between review pathway requirements for large versus small companies.

The ACR urged the FDA to further specify how qualified third-party validation and/or registry services can inform the various components of Pre-Cert, including SaMD review and real-world performance assessments.

The FDA is expected to evolve and expand the pilot program through 2019. The program will initially leverage the flexibility inherent in the regulatory framework of the FDA’s De Novo Pathway.

For questions about the Software Pre-Cert Pilot Program, or the FDA’s other digital health initiatives, please contact Michael Peters, ACR Director of Regulatory and Legislative Portfolio, at or 202-223-1670 ext. 4546.