The digital health software precertification program is FDA’s strong footstep in leading the way to support the inclusion of the digital world in the US healthcare industry. As part of FDA’s digital health innovation action plan, the pre-cert program was announced in July 2017, and since then has gained tremendous acceptance by the industry...

1. FDA’s Digital Software Pre-Certification
Program
By: Nikita Angane, MS
The digital health software precertification program is FDA’s strong footstep in leading the way
to support the inclusion of the digital world in the US healthcare industry. As part of FDA’s
digital health innovation action plan, the pre-cert program was announced in July 2017, and since
then has gained tremendous acceptance by the industry.i
The software precertification program is an effort taken by the FDA to streamline the traditional
regulatory framework to support and adapt to the digitization wave in the medical world. Unlike
traditional medical devices, the digital devices sometimes referred to as SaMD (software as a
medical device) can undergo modernization at a much faster pace, and FDA intends to adapt to
the same level of approving/clearing of the SaMD’s. The idea behind this program is also to
reduce the mountainous submissions that the manufacturer would have to prepare if they propose
an update or a safety change to the software products.
Here the FDA takes an ISO certification stance. The program is conceived for the software
product manufacturer/company and not for a product; which is currently the FDA’s approach
towards traditional medical devices. Under the pre-certification program, the manufacturers of
software-based medical devices will receive a certification for demonstrating a healthy quality
system and organizational structure. The pre-certified manufacturers will then be able to market
their low-risk devices without FDA pre-market review and would still be affirmed to meet the
same safety and effectiveness standards expected out of traditional medical devices. The FDA
plans on incorporating the risk classification criteria for SaMD set by the International Medical
Device Regulatory Forum (IMDRF) to determine the regulatory pathway for each risk category.ii
FDA launched the software pre-certification pilot program in August 2017iii to explore and
evaluate the model. Out of more than hundreds of applications, nine participants were selected to
be included in the pilot study including digital giants like Apple, Fitbit, and Samsung. The pilot
program is currently based on five excellence principles, which are:- patient safety, product
quality, clinical responsibility, cybersecurity, and proactive culture.ii A Software pre-certification
program working model version 0.1 was released in October 2017, which was then superseded
by version 0.2 in June 2018. FDA anticipates the first version of the program- Pre-cert 1.0 to be
available for pilot testing in 2019. FDA also assured that timely guidance and information
sessions will be provided for the industry to prepare themselves for changes proposed in the
future.

2. Page 2 of 4
The pilot program was open for public comments until June 2018 and it received 94 comments
on the docket from companies like Boston Scientific, GE healthcare and J&J[who is also a
participant in the pilot study]. Several questions were raised by medical device and software
experts including whether the software certification can be transferred from one company to
another in case of a merger or a takeover.iv According to the pilot program roadmap published in
April 2018, the pilot test should now be in its integrate-simulate and Pre-launch stage.v
If the FDA is successful in implementing the certification program, it will surely hightail the
immersion of the digital world in the healthcare arena, by allowing them to better focus on the
innovation rather than the complex regulatory network. As a result, safe software products will
gain flash entry into the US health market.
If you have any questions, or would like to learn more about the program, Please Call (248) 987-
4497 or send an email to info@emmainternational.com.

3. Page 3 of 4
i
FDA ( July 2017) FDA Announces New Steps to Empower Consumers and Advance Digital
Healthcare retrieved on 11-12-2018 from
https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm612014.htm
ii
FDA - Digital Health Software Precertification (Pre-Cert) Program
retrieved on 11-12-2018 from
https://www.fda.gov/medicaldevices/digitalhealth/digitalhealthprecertprogram/default.htm#progr
am
iii
FDA ( August 2017) Digital Health Innovation Action Plan retrieved on 11-12-2018 from
https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf
iv
Regulations.gov- Fostering Medical Innovation: A Plan for Digital Health Devices; Software
Precertification Pilot Program retrieved on 11-12-2018 from
https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=50&
dct=PS&D=FDA-2017-N-4301
v
FDA (April 2018) Precertification (Pre-Cert) Pilot Program: Milestones and Next Steps
on 11-12-2018 from
https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.ht
m and
https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/UC
M605690.pdf

4. Page 4 of 4
For Katie’s use
https://medicalfuturist.com/10-exciting-digital-health-stories-2017
https://www.medicalplasticsnews.com/news/opinion/connected-medical-devices/
You can use FDA logo maybe since it’s the FDA program