> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Software Pre-Cert Program Far from Operational: Report
- URL: https://www.fdaweb.com/software-pre-cert-program-far-from-operational-report/
- Published: 2020-09-16T12:00:00.000Z
- Updated: 2026-09-14T16:28:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147667

An update on the status of the FDA software precertification program [indicates](https://www.fda.gov/media/142107/download?ref=fdaweb.com) the evaluation of the pilot program will continue, apparently with no additional pilot participants and no indication that the program will be operational any time soon. Attorneys **Allison Fulton** and **Julia Kadish** (SheppardMullin) [write](https://www.fdalawblog.com/2020/09/articles/digital-health-medical-devices/fda-software-pre-cert-pilot-program/?utm%5Fmedium=email&utm%5Fcampaign=FDA%20Law%20Update%20Blog&utm%5Fcontent=FDA%20Law%20Update%20Blog+CID%5F9095516c9127f936468e73c84002d3eb&utm%5Fsource=Create%20Send%20campaigns&utm%5Fterm=here) in their firm’s *FDA Law Update Blog* that the pre-cert program has four essential components: excellence appraisal, review determination, streamlined review, and real-world performance.

The attorneys say the update gives detail on the agency’s activities under its test plan and key learnings on the excellence appraisal, streamlined review, and real-world performance.

“The agency seems to be years from implementing, or even beta-testing, a pre-certification program,” Fulton and Kadish conclude. “Substantial work appears to be needed in each of the program’s key components, and the agency plans on engaging stakeholders to explore approaches and methodologies for certain components.”