In mid-2017, the U.S. Food and Drug Administration (FDA) published the Digital Health Innovation Action Plan. At the same time FDA’s current Commissioner, Scott Gottleib, MD, launched the Software Precertification Pilot Program, simply called Pre-Certification or Pre-Cert program.
Uniqueness’s of Digital Health Technologies
This program, developed under FDA’s Center for Center for Devices and Radiological Health (CDRH), recognizes the uniqueness’s of digital health technologies, in their promise to improve the health of the public and the frequent iterative process of product improvements. A key aim of Pre-Cert is to assure delivery and access to high-quality, safe and effective digital health products in a timelier and less burdensome process.
FDA’s Steps to Create Pre-Cert
To create Pre-Cert, FDA is conducting a pilot with nine companies. The pilot, considered a first step in this process, is designed to collaborate with the full ecosystem of stakeholders to achieve success. Phase 1 included site visits to the pilot organizations. Phase 2 was a public workshop, Fostering Digital Health Innovation: Developing the Software Precertification Program, held January 30–31, 2018.
Public Workshop on Pre-Cert
This public workshop delved into the program’s progress and sought input from the nine pilot players on their visions for the Pre-Cert program. To be clear, these nine entities were not chosen by FDA as the first to obtain Pre-Cert status, rather they’re helping to design the process FDA will put in place. Complete archives of the workshop are available.
Top Take Aways from Malinda Peeples
Malinda Peeples, RN, MS, CDE, WellDoc’s VP, Clinical Services, Programs and Research, attended this workshop. She has been involved in the science and clinical implementation of digital health therapeutics for nearly a decade. She shares her top line take aways here:
- I was struck by the tremendous passion and dedication in the room from every attendee whether from FDA, industry or other type of organization. There was shear excitement about the opportunity to be involved at the forefront of this novel FDA undertaking and to improve the peoples’ lives.
- By observing the gamut of representatives in attendance it was clear that FDA is leveraging broad base input to develop a process that will be understood and supported by everyone. Attendees represented technology vendors, health plan administrators, professional medical associations, capability improvement model experts, quality consultants (e.g. Baldridge Performance Excellence Program, Capability Maturity Model Integration) and others.
- Clinically validated and FDA-cleared digital therapeutics will enable significant changes in the delivery of health care from the perspectives of convenience and quality over the next decade and beyond. The rigor with which FDA’s Pre-Cert program is being developed will make it easier for clinicians on the front lines of care delivery to know and trust the “certified vendors” for digital solutions. This will provide a level of confidence for clinicians when they choose digital therapeutics and hopefully their utilization.
- Once the Pre-Cert program is finalized and launched it will be critical that the public understands that a main focus of FDA’s oversight and review of digital health tools is to ensure the safety and effectiveness of these tools.
- It is rewarding to observe FDA’s proactive and rigorous approach to developing this innovative and far-reaching program. Their commitment to co-create this program with technology vendors to increase the speed with which new and innovative solutions are available to enhance care and outcomes is laudable.
- It was clear that collaboration among all of the entities involved will help achieve valuable cross fertilization of knowledge and ideas. This should result in a well vetted process.
Follow the evolution of this novel program on Twitter at: #FDAPreCert
Check out the top line take aways from this public workshop from digital health innovator, Anand Iyer, PhD, MBA, WellDoc’s Chief Strategy Officer.