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.

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:



Corporate Office

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