Medical Devices

Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018

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The Food and Drug Administration (FDA), announced the following public workshop entitled "Fostering Digital Health Innovation: Developing the Software Precertification Program." The purpose of the public workshop was to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take in to account real world evidence while incorporating principles established through international harmonization.

Date, Time and Location

This meeting was held January 30-31, 2018, beginning at 8:30 am – 5:00 pm at the following location:

National Institutes of Health (NIH) Campus
9000 Rockville Pike
Ruth L. Kirschstein Auditorium
Natcher Conference Center, Bldg. 45
Bethesda, MD, 20892

The entrance for the public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed.

Webcast Archive

Agenda

Presentation Slides

Transcripts

DAY 1 - Setting the Stage

Time

Topic

Name of Speaker/Moderator

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

 

Day 2: Co-Creating the Program

Time

Topic

Name of Speaker/Moderator

8:30-8:50AM

Welcome and Day 2 Kick-Off
This session will summarize observations from Day 1 and encourage active participation from attendees.

Bakul Patel – FDA Associate Center Director for Digital Health

8:50-9:05AM

Break-Out Session Logistics
The speaker will briefly explain break-out session logistics.

Dr. Marisa Cruz– FDA Medical Officer

9:05-10:35AM

Break-Out Session 1: Drivers of Excellence and Associated Metrics
This session will be dedicated to discussing drivers of excellence and their associated metrics. The purpose of the breakout session is to refine the framework, identify gaps and provide an opportunity for participants to share their perspectives. The audience will be split into groups and each session will be moderated by an FDA representative. This session will be followed by a share/review session where each breakout group summarizes their discussions and shares their insights with the rest of the audience.

 

10:35-10:45AM

Break

 

10:45AM-12:00PM

Share and Review

Dr. Marisa Cruz– FDA Medical Officer

12:00-1:00PM

Lunch

 

1:00-1:45PM
 

Break-Out Session 2: Excellence in Results and Outcomes
This session will focus on downstream results and outcomes that are reflective of excellence. The purpose of the session is to identify performance and perception metrics that are key to an assessment of excellence but have not yet been captured. This session will be followed by a share/review session where each breakout group summarizes their discussions and shares their insights with the rest of the audience.
 

 

1:45-2:30PM

Share and Review

Dr. Marisa Cruz– FDA Medical Officer

2:30-3:15PM

Break-Out Session 3: Aggregation Tools and Scorecards
This session will discuss data aggregation and scoring methodologies, drawing from dashboard examples from the pilot participants.  The break-out groups will discuss how data should be aggregated moving forward and how it could be used to grant and maintain precertification.  This session will be followed by a share/review session where each breakout group summarizes their discussions and shares their insights with the rest of the audience.

 

3:15-3:30PM

Break

 

3:30-4:15PM

Share and Review

Dr. Marisa Cruz– FDA Medical Officer

4:15-5:00PM

Final Remarks and Next Steps

Bakul Patel – FDA Associate Director for Digital Health

 

Digital Health Innovation Action Plan

Registration to Attend the Workshop

Online registration is closed as of January 18, 2018. To register for the webcast please email CDRHpublicmeetings@fda.hhs.gov.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov

Contact Us

For questions regarding workshop content please contact:

Maggie Fu, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5567, Silver Spring MD  20993, 301-796-6657, maggie.fu@fda.hhs.gov

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