FDA’s Digital Software Pre-Certification Program

FDA’s Digital Software Pre-Certification Program

The digital health software pre-certification 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

The software pre-certification 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.2

FDA launched the software pre-certification pilot program in August 20173 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culture.2 A Software pre-certification program working model version 0.1 was released in October 2017, which was then superseded by version 0.2 in June 2018.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.

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.4 According to the pilot program roadmap published in April 2018, the pilot test should now be in its integrate-simulate and Pre-launch stage.5

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.


1 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

2 FDA – Digital Health Software Precertification (Pre-Cert) Program retrieved on 11-12-2018 from https://www.fda.gov/medicaldevices/digitalhealth/digitalhealthprecertprogram/default.htm#program

3 FDA ( August 2017) Digital Health Innovation Action Plan retrieved on 11-12-2018 from https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf

4 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

5 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.htm and https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/UCM605690.pdf

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