A summary provided by Medtronic, PLC
Members, as many of you know the FDA is piloting a Pre-certification program for certain digital health technology products. On January 30-31st the FDA hosted a public workshop. Representatives of Medtronic that participated shared their high-level notes with Medical Alley Association for the benefit of interested parties that were not able to participate. They are below.
Additional information can be found in these documents:
Digital Health Pre-Cert Pilot Program Update
Software precertification Program Excellence Model
Key Takeaways:
- Goal of the program is to maintain FDA’s high standard for Safety and Effectiveness, while introducing both simplicity and flexible regulatory pathways
- Pre-certification will be a firm-based (not product-based) approach and may have multiple certification tiers
- FDA was strongly encouraging participants to not think in traditional terms of compliance or submissions, rather asked them to think & talk in terms of “how”, such as how they knew the product was ready for market or how they knew it was the right product for the patient, to inform the “market ready” baseline
- Once developed, the program will not be static but evolve continuously to respond to ever-changing conditions
- Program is intended to accommodate fast software development timelines, evolving areas of concern (e.g. security, distribution), and potential exponential increase in submissions
- FDA is truly being collaborative. Dr. Jeff Shuren, CDRH director, also expressed his desire for FDA to be an equal partner at the table
- Program is intended to be scalable from the start, and effective for small to large companies and low risk to high risk software
- So far, the program has represented a true paradigm shift and it will take companies time to get used to new terminology and ways of thinking
- Target launch of program by start of 2019
Identified Challenges Moving Forward
- Until the program has matured we will not know to what extent pre-certification will impact/augment/replace the premarket review process
- What matters to payors is clinical evidence/outcomes and how pre-certification may influence the burden of clinical evidence (e.g. from pre-market to more post-market activities) is a big area of debate
- The extent of transparency of the basis for a company’s pre-certification to the public has yet to be defined, but there was almost unanimous agreement this was important
- Determination of an appropriate tiering scheme for pre-certification
- The concept of traditional Design History Files does not make sense to many young software companies due to better existing tools and methodologies, prompting evaluation of viable alternatives
