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:


including FAQs at:


Milestones and next steps can be found at:


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:


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.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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