FDA Digital Health Precertification (Pre-Cert) update

FDA is entering the test phase of its Digital Health Precertification (Pre-Cert) Pilot Program. General information on this program can be found at:

https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm

including FAQs at:

https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm577330.htm

Milestones and next steps can be found at:

https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.htm

Generally, this program is for some of what FDA refers to as Software as a Medical Device (SaMD).  Companies such as Apple and Fitbit (among others) are involved in this pilot program.  On January 7, 2019 FDA published its Software Precertification Program: 2019 Test Plan. One of the goals is to provide a streamlined premarket submission process for companies that have been appraised and meet certain Excellence Appraisal elements. The test plan includes internal FDA retrospective review of prior traditional premarket submissions in comparison to reviews using the pre-certification approach to streamline the submission. In addition prospective premarket review using the traditional and pre-cert approaches will be performed to asses if there is equivalence for determining reasonable assurance of safety and effectiveness for a SaMD product prior to its introduction to the market, as compared to the traditional paradigm. FDA also hopes that the results of this test will provide evidence to develop a framework for a future Pre-Cert model, in which lower-risk products could be introduced directly to market by firms that have successfully been excellence appraised. Clearly a major change in FDA’s approach to software regulation at least for SaMD that is considered lower risk. The full test plan is at:

https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/UCM629277.pdf

John Murray, a 25 year veteran of FDA, is now a Partner at SoftwareCPR® (See Post)  John was intimately in involved in the Pre-Cert pilot while at FDA and is now available for consulting and training in many aspects of FDA regulation.  Click John Murray for more information on his background in FDA regulation and International Standards on our Team page.

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