An Update on FDA’s Digital Software Pre-Certification Program

by | Jan 18, 2019 | FDA, Medical Devices, Quality Systems, Regulatory

On January 7th, FDA released a working model for the software pre-certification pilot program version 1.0. The working model is open for public comments on the docket until March 8th, 2019. In our blog FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGRAM, we discussed how the program will benefit digital device manufacturers bring their devices to the US market faster without having to go through the complex and time consuming regulatory approval process.

FDA released a test plan for the pre-cert program which summarizes how the FDA will be implementing and evaluating the pre-market submissions of the pilot participants. According to the test plan, SaMD (Software as a Medical Device) companies will be evaluated based on five excellence appraisal elements, which are: 1

Patient Safety,

Product Quality,

Clinical Responsibility,

Cybersecurity Responsibility,

and Proactive Culture.

Retrospective testing will be used to review SaMD regulatory submissions from the past to determine what type of information the pre-certified companies should include in their pre-market application to be able to conduct a streamlined review of the software products which the pre-certified companies are eligible for.

The test plan includes a review of the real-world performance data of the device, submitted by the company to the FDA, to determine how it will help to preserve the safety and effectiveness of the device.2

The FDA plans to utilize the De Novo classification process to review SaMD under the pre-cert program because it anticipates that majority of the SaMD will fall under the De Novo classification, and hence can be cleared through a streamlined process.Companies will have the option of a “Review Pathway Determination Pre-Submission (Pre-Sub)”. Companies would then submit the appropriate application (De Novo Requests or 510(k) submissions, as appropriate) and shall include the requirements of a traditional application packet as well. A comprehensive review of the data from the excellence appraisal of the company, the review determination pre-sub, and the application from the pilot participants will enable the FDA to design a streamlined review program for the marketing applications submitted from pre-certified companies in the future.

The streamlined ‘Pre-Cert De Novo’ request will contain the data that was not already received by the FDA through the excellence appraisal and the required information to determine that the device is of low to moderate risk. The Pre-Cert De Novo Request would include the submitter’s certification that it is following the processes and procedures that FDA reviewed and documented during the Excellence Appraisal. Modifications to the device granted under a De Novo request will not require a new 510(k) unless the modification changes the intended use, or if the modification introduces high risks to the device.

As with the De Novo, a pre-certified company may opt to submit a ‘Pre-Cert 510(k)’ if it is able to establish substantial equivalence, which includes product-specific submission requirements and leverages other submission requirements already documented during the Excellence Appraisal.

FDA anticipates that the review of the Pre-Cert 510(k)’s and De Novo’s would be more efficient than its traditional counterparts. Metrics and relevant data will be captured by the FDA to determine how the pre-cert model confirms that there is reasonable information to assure the safety and effectiveness of the device.

You can submit your suggestions or comments on FDA’s software pre-certification working model 1.0 using the following link:


For any other questions that you may have about the program, please contact us at 248-987-4497 or

1FDA (Jan 2019) Software Precertification Program: Working Model – Version 1.0 retrieved on 01-10-2019 from

2FDA (Jan 2019) Software Precertification Program: 2019 Test Plan retrieved on 01-10-2019 from

3FDA (Jan 2019) Software Precertification Program: Regulatory Framework retrieved on 01-10-2019 from


Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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