EMERGO BY UL SUMMARY OF KEY POINTS:

• US FDA has issued a new regulatory framework, working model and test plan for its Pre-Cert pilot program for Software as a Medical Device (SaMD).
• The FDA Pre-Cert regulatory pathway would utilize FDA’s De Novo classification request framework for qualifying SaMD products.
• FDA is accepting comments on these Pre-Cert updates through March 8, 2019.

The US Food and Drug Administration has issued major updates to its Software Precertification Program (Pre-Cert) pilot program for software and digital technologies that qualify as medical devices, including a regulatory framework, test plan and revised working model.

The three major Pre-Cert updates include:

• A Pre-Cert Working Model Version 1.0 describing major program components and how they interact;
• A Pre-Cert 2019 Test Plan laying out how FDA will confirm assurances of safety and effectiveness for software products evaluated under the program;
• A Pre-Cert Regulatory Framework describing the agency’s plans to implement the pilot program.

Originally launched in 2017, the Pre-Cert pilot was developed to establish a more effective US regulatory pathway for software as a medical device (SaMD) and related digital health technologies whose innovative characteristics are not sufficiently addressed via conventional FDA premarket review processes.

The new Pre-Cert regulatory framework

First, FDA proposes a regulatory framework whereby implementation of the Pre-Cert pilot program will occur via the agency’s De Novo premarket pathway in order to establish elements of an effective regulatory model for qualifying SaMD products.

FDA premarket applicants whose SaMD products are eligible for De Novo classification may opt for Excellence Appraisals according to the agency’s latest Pre-Cert working model; results of such appraisals would be used to support applicants’ De Novo requests, as well as for future 510(k) or other premarket submissions.

Emergo by UL will examine FDA’s new Pre-Cert regulatory framework more closely in a future blog post.

The latest Pre-Cert working model: What’s new

Version 1.0 of the Pre-Cert working model, first rolled out in early 2018, includes additions and clarifications covering areas such as the program’s Total Product Lifecycle approach; Excellence Appraisal level descriptions; premarket review pathway determinations; and streamlined Pre-Cert review elements and processes.

Working model revisions of particular interest include:

• Excellence Appraisals: FDA will assume primary responsibility for Pre-Cert Excellence Appraisals for 2019, but will consider accreditation of third parties to conduct such appraisals in the future.
• SaMD review pathways: FDA has identified SaMD product-level elements—core functionality of the product, device description and performance, for example—to be used to determine SaMD risk categories and Pre-Cert review pathways.
• Streamlined reviews: Elements necessary for streamlined Pre-Cert premarket reviews should include clinical algorithms, cybersecurity-related information such as threat models, pertinent pathway-specific information such as 510(k) substantial equivalence claims, and software architecture and revision history.
• Real-world performance: Version 1.0 of the working model includes updated descriptions and examples of real-world performance analysis plans.

FDA’s 2019 Test Plan for the Pre-Cert program

FDA has also developed a Pre-Cert test plan in 2019 before fully establishing the program as an alternative US market pathway for qualifying SaMD products. The agency intends to test the program in two ways:

• First, internally via retrospective tests of SaMD premarket submissions already reviewed by FDA;
• Second, prospectively using Pre-Cert pilot program participants that volunteer to undergo testing.

“The primary purpose of this Test Plan is to assess whether Excellence Appraisals and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a SaMD product prior to its introduction to the market, as compared to the traditional paradigm,” FDA states regarding the test plan.

For 2019, the agency will apply its test plan to two types of SaMD applicants: certain SaMD De Novo requests, to test the special controls concept including Excellence Appraisal components and post-market data collection requirements; and certain SaMD 510(k) submissions, which will undergo testing as if they were follow-on 510(k) applications for devices classified using Pre-Cert De Novo requests.

FDA will seek premarket submissions representing the broadest spectrum of SaMD developers possible for testing—small and large developers, high- and low-risk SaMD products, and digital technology developers more so than conventional device manufacturers.  

Each test case will undergo two evaluations:

• Pre-Cert pathway review, including Excellence Appraisal, Review Pathway Determination, Streamlined Review and Real-world Evaluation components;
• Traditional FDA review to provide a comparison of premarket review outcomes.

Additional US FDA SaMD and medical device regulatory information from Emergo by UL:

• US FDA 510(k) consulting for medical device and IVD companies
• FDA medical device classification consulting
• Regulatory consulting for telehealth and mobile medical apps
• Whitepaper: FDA regulations for novel and innovative products