FDA Software Precertification Pilot Ends

In September 2022, the FDA Software Precertification Pilot Ends, or has officially “completed” the Software Precertification (Pre-Cert) Pilot Program.  See: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program?utm_medium=email&utm_source=govdelivery

The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of their products once they reach the U.S. market.  SoftwareCPR Post from 2019

The major findings in this report:

  • The Pilot Program is complete, and for now there is no Software Pre-Certification Program
  • FDA has determined that the approach described in the pre-certification working model is not practical to implement under our current statutory and regulatory authorities.
  • The pilot informed what new statutory authorities could support a future regulatory paradigm that builds on these concepts.
  • Appropriate new legislative authority would be necessary to support the development and implementation of a new regulatory paradigm.

In the meantime, FDA, with leadership from CDRH’s Digital Health Center of Excellence, will continue to develop policies and tools within current authorities to improve the efficiency and effectiveness of regulatory oversight, including through collaborative engagement with the public, such as the Medical Device Innovation Consortium (MDIC).

Download the report:  The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings


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.

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.

Registration Link:




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:

Register Now



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

Corporate Office

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