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# Software Pre-Cert Pilot Program
- URL: https://www.fdaweb.com/software-pre-cert-pilot-program/
- Published: 2019-01-07T12:00:00.000Z
- Updated: 2026-09-15T00:52:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143098

FDA has issued a new [Software Precertification (Pre-Cert) Pilot Program](http://app.info.fda.gov/e/er?utm%5Fcampaign=Digital%20Health%20Update%3A%20New%20FDA%20Pre-Cert%20Working%20Model%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6203&elqTrackId=DCCAC7D917A4AD871348D0CC40582525&elq=328711e00da4430f8967728832917fd1&elqaid=6441&elqat=1) [working model 1.0](http://app.info.fda.gov/e/er?utm%5Fcampaign=Digital%20Health%20Update%3A%20New%20FDA%20Pre-Cert%20Working%20Model%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6202&elqTrackId=15DD49F3C3C2F4D03C00246675E2337B&elq=328711e00da4430f8967728832917fd1&elqaid=6441&elqat=1),[ Test plan](http://app.info.fda.gov/e/er?utm%5Fcampaign=Digital%20Health%20Update%3A%20New%20FDA%20Pre-Cert%20Working%20Model%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6206&elqTrackId=E8BDC6A652F7335D4421B59A85DEE83D&elq=328711e00da4430f8967728832917fd1&elqaid=6441&elqat=1), and [regulatory framework](http://app.info.fda.gov/e/er?utm%5Fcampaign=Digital%20Health%20Update%3A%20New%20FDA%20Pre-Cert%20Working%20Model%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6205&elqTrackId=0D8E7F3D8C1C164075E77445B4EBA977&elq=328711e00da4430f8967728832917fd1&elqaid=6441&elqat=1) to explain how it envisions regulating digital health devices by looking at information across the total product lifecycle. The pilot is now entering the test phase that will allow FDA to “assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a software device prior to its introduction to the market, as compared to the traditional paradigm,” a notice says. (XXINSRT LINKXXX)

FDA says it is seeking comments on the working model [through the public docket by 3/8.](http://app.info.fda.gov/e/er?utm%5Fcampaign=Digital%20Health%20Update%3A%20New%20FDA%20Pre-Cert%20Working%20Model%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6207&elqTrackId=9FDD45595129F638102939EA34507028&elq=328711e00da4430f8967728832917fd1&elqaid=6441&elqat=1) Additionally, the agency will host a [user session](http://app.info.fda.gov/e/er?utm%5Fcampaign=Digital%20Health%20Update%3A%20New%20FDA%20Pre-Cert%20Working%20Model%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6204&elqTrackId=0AE7B77CB02C2795B404D85CC6036E2B&elq=328711e00da4430f8967728832917fd1&elqaid=6441&elqat=1) on 2/7 to help clarify software developers’ questions about the program.