Yuan愿 Song宋 Professor, Data Scientist Duke University

1. Digital Health Software
Precertification (Pre-Cert) Program
Yuan Song
Professor, Data Scientist
Duke University
1Copyright by Bigfish HealthFeb.2019

2. DISCLAIMER
The views and opinions presented represent those of the
speaker and should not be considered to represent advice
or guidance on behalf of the Food and Drug Administration.
Feb.2019 Copyright by Bigfish Health 2

3. Francis Collins MD, PhD, Director,
National Institutes of Health FDA and NIH

4. Digital Health Software Precertification (Pre-Cert) Program
• Figure 1. A
reimagined
approach for
the regulation
of software
Feb.2019 Copyright by Bigfish Health 4

5. Digital Health Software Precertification (Pre-Cert) Program
• Figure 2.
Description of
SaMD, including
possible data
sources from
which inputs
are derived and
that may be
used for one or
more medical
purposes.
Feb.2019 Copyright by Bigfish Health 5

6. Digital Health Software Precertification (Pre-Cert) Program
• Figure 3. Software
Pre-Cert Program
Components
Feb.2019 Copyright by Bigfish Health 6

7. Digital Health Software Precertification (Pre-Cert) Program
Feb.2019 Copyright by Bigfish Health 7
• Figure 4. Total
Product Lifecycle
Approach of the
Software Pre-Cert
Program

8. Digital Health Software Precertification (Pre-Cert)
Program
Feb.2019 Copyright by Bigfish Health 8
• Figure 5.
Evaluation
of
Premarket
Submission
Elements
throughout
a Total
Product
Lifecycle.

9. Digital Health Software Precertification (Pre-Cert) Program
Feb.2019 Copyright by Bigfish Health 9
• Figure 6.
Conceptu
al
Framewo
rk for
Excellenc
e
Appraisal

10. Digital Health Software Precertification (Pre-Cert) Program
Feb.2019 Copyright by Bigfish Health 10
• Figure 7.
Conceptua
l
framework
for
conducting
a generic
interactive
Streamline
d Review
of a SaMD
from a pre-
certified
organizatio
n.

11. Digital Health Software Precertification (Pre-Cert) Program
Feb.2019 Copyright by Bigfish Health 11
• Figure 8.
RWPA
Post-
Launch
Product
Monitoring
DomainsFi
gure 8.
RWPA
Post-
Launch
Product
Monitoring
Domains

12. Copyright by Bigfish Health 12
Thank you
Q&A
Feb.2019