8:30-8:45AM

Keynote Opening
FDA Leadership will provide a high-level background on the evolving field of digital health technology and FDA’s regulatory efforts to promote the public health by assuring safety, effectiveness and supporting innovation.

Dr. Jeff Shuren – Center Director of CDRH

8:45-9:30AM

Introduction to the Software Precertification Pilot Program
This session provides a review of the Precertification Pilot effort to date, including the history of the project, accomplishments and milestones, lessons learned from engagement with the Pilot Participants, and the objectives of this workshop.

Bakul Patel – FDA Associate Director for Digital Health

9:30-10:45AM

Panel 1: Pilot Participant Experience
for Digital Health
This panel will provide the public with an opportunity to learn about the project through the perspective of the pilot participants.  Pilot participants will share their experiences engaging with the FDA and mapping their processes and metrics to the excellence principles.  They will also discuss any changes in their understanding or expectations of the Pilot since they were initially selected. This panel session will include an opportunity for the audience to ask questions of the panel.

Bakul Patel – FDA Associate Director for Digital Health

10:45-10:55AM

Break

10:55-11:30AM

Panel 2: Q&A with the FDA Pre-Cert Core Team 
Audience will have the opportunity to ask the FDA Precertification Pilot Core Team clarifying questions about the approach and the scope of the program.

Bakul Patel – FDA Associate Director for Digital Health

11:30-12:00PM

Open public comment focused on Panels 1 and 2
Participants who have requested to speak during the registration process will be contacted in advance of the meeting with instructions and details.

Dr. Marisa Cruz– FDA Medical Officer

12:00-1:00PM

Lunch

1:00-2:00PM

Panel 3: Perspective from Healthcare Stakeholders
This panel session will allow external stakeholder groups, including payers, providers, hospitals, and patients, to discuss how a precertification program would be understood and perceived by their communities.  

Cara Tenenbaum – FDA Policy Advisor

2:00-2:50PM

Panel 4: Input from other Digital Health Industry Trade Groups and Associations
This panel session will include short presentations from digital health industry trade groups and associations who will share ideas and approaches for understanding organizational excellence.

Catherine Bahr – FDA Digital Health Team Expert

2:50-3:00PM

Break

3:00-4:30PM

Panel 5: Learning from Excellence Models used in other Sectors
This panel session will provide an opportunity to learn from other sectors who utilize different models for measuring organizational excellence.

Francisco Vicenty – FDA Program Manager

4:30-4:50PM

Open public comment focused on Panels 3, 4, and 5
Participants who have requested to speak during the registration process will be contacted in advance of the meeting with instructions and details.

Dr. Marisa Cruz– FDA Medical Officer

4:50-5:00PM

Closing