FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework

On September 14, the U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot Program, which ran in 2019 with 9 company participants. The Pre-Cert program is meant to fast-track digital health products by reducing regulatory hurdles for developers of Software as a Medical Device (SaMD), i.e., software-only products that meet the Federal Food, Drug, and Cosmetic Act definition of a medical device through up-front evaluation of the company’s processes and capabilities. The update highlights what the agency learned from activities conducted to test the program as presently envisioned, and how it will use this information for the next iteration of building and testing. FDA’s update indicated that “more work is needed” to understand how information collected to address the product’s total life cycle namely during Excellence Appraisals, Review Determination and Real-World Performance monitoring can be leveraged to support the Streamlined Review for introduction of new devices to market.

The Pre-Cert Program is an effort by FDA to develop a regulatory framework for software medical device products through which a company is deemed to have good internal design, development, and production processes/practice, and accordingly is given a streamlined (or exemption from) pre-market review for future software products which meet the statutory definition of a medical device. Specifically, program eligibility is anchored in a determination by FDA that a manufacturer has demonstrated a culture of quality and organization excellence, coupled with a commitment to monitoring the real-world performance of its products and addressing any issues that may arise.

In April 2018, as we discussed here, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including a working model (v0.1) reflecting the agency's vision of the pilot and outlining its most critical components. Subsequently, in January 2019, this working model was updated (v1.0) and a corresponding Test Plan released to guide the Pilot program.

FDA has still not determined which specific regulations and authorities it would need to make Pre-Cert a reality, and has again noted that it will consider obtaining legislative authority to fully implement this as a new pathway to market for SaMD. While this latest update offers no specific timeline for the program’s official enactment, it does outline next steps in a “development roadmap,” depicted here:


FDA’s update highlights the following findings of the pilot program thus far:

  • A mock “Excellence Appraisal,” which aims to measure whether an organization’s values, goals, and objectives align with Pre-Cert's “Excellence Principles,” and relies on remote pre-work and objective evidence, appears to be a viable alternative to a multi-day on-site visit.

    • FDA confirmed that the elements identified in the Pre-Cert Program model can be demonstrated, and that they provide a comprehensive view of an organization’s capabilities.

    • The software development and validation information evaluated during mock Excellence Appraisals provided additional context to the Streamlined Review process.

  • Streamlined Review, which works alongside the Excellence Appraisal was found to require additional exploration and testing.

    • FDA found that there was variability regarding the specific information needed from the masked software review elements to achieve an outcome comparable to current device review practices.

    • FDA will continue to explore structured ways for manufacturers to define their SaMD products consistently, while leveraging the International Medical Device Regulators Forum (IMDRF) framework with the goal of ensuring a globally harmonized approach.

  • Real-World Performance data collection allowed for the observation of several important measures, including Human Factors Usability and Engineering and metrics that provide assurance that safety risks are managed and mitigated in a timely way. However, more testing is needed to understand how Health Benefit information may be observed in real-world performance data. The agency will also evaluate best methods for collection of such data that allow integration into a total product lifecycle approach.

    • Work continues with the pilot participants and test case companies to outline the framework and mechanics for collecting Real-World Performance data, including exploring less reliance on manual collection of information, and more focus on ways to use technology – such as automated remote access to digital data – to collect SaMD product information once it is on the market.

Using the Pre-Cert development method of building, testing, and iterating, FDA is evaluating learnings from the testing activities, and it will iterate and revise its testing approach. Thus far, the agency has learned that program refinements are needed to drive process repeatability, improve the quality and quantity of information, provide greater clarity to internal and external stakeholders, and reduce associated time burdens. FDA has also released a video that explains the agency’s vision for Pre-Cert, and how the agency’s current work with pilot participants to define data models will support the future program. 

As part of the next steps, FDA intends to outline scenarios to test least burdensome approaches to establishing a safe and effective, consistent, total product lifecycle approach to regulation of SaMD through the Pre-Cert program. In addition, the focus in the near future will be on integrating and assessing the interfaces between the four components of the Pre-Cert program (Excellence Appraisal, Review Determination, Streamlined Review, and Real-World Performance), including further assessment and development how the information collected during Excellence Appraisals, Review Determination and Real-World Performance monitoring can be leveraged for Streamlined Review. No timeline is provided for the next stages of development and FDA indicates that it will continue to work with the 9 existing pilot participant companies to further develop the program.


Authored by Jodi K. Scott, Lina Kontos, Meredith Manning, and Suzanne Levy Friedman


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