Digital Health pre-cert program update

On September 14, 2020 the Digital Health Team at FDA provided a 2020 Update on the Software Precertification Pilot Program. The announcement is a short 8-page document.

The document provides the details that are driving program development. It contains a considerable amount of information that may take a few reads to fully understand. On my first read I was primarily interested in:

  • When will the pre-cert pilot become an established program?
  • How do I get my product to market if pre-cert is only a pilot?
  • Will the pre-cert program require new legislative authority?

The following items address my primary interest today:

  1. The Digital Health Team at FDA believes that refinements are needed across the program to drive repeatability of the processes, improve the quality and quantity of information, provide clarity to internal and external stakeholders, and reduce the time burden on both internal and external stakeholders
  2. As the FDA continues to identify, evaluate, and improve on Pre-cert Pilot Program approaches to assure safety and effectiveness of products that require marketing authorization, the FDA’s marketing authorizations for these products will continue under the FDA’s existing regulatory pathways.
  3. The Agency will continuously assess and evaluate the readiness of the Pre-Cert Program before progressing to the next phases of development and will consider obtaining legislative authority to fully implement it as a new pathway for SaMD.
  4. The transition from the Pilot to Program remains “yet to be determined.”
About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.