FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

by King & Spalding

On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software Precertification Program: A Working Model (Version 1.0); (2) the Software Precertification Program: 2019 Test Plan; and (3) the Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities.

These documents—the Working Model, the Test Plan, and the Regulatory Framework—are critical to the digital health community, including artificial intelligence companies, because they offer an opportunity to engage in the development of what hopefully will be a much more efficient, effective, and flexible system for approving cutting-edge software and digital health devices. The documents also mark the beginning of the long-anticipated “test phase” of the Pre-Cert Pilot Program and, eventually, the launch of the final Pre-Cert Program.


FDA Commissioner Scott Gottlieb first announced FDA’s intention to offer the Pre-Cert Pilot Program as part of an initiative to advance “Digital Healthcare” on July 27, 2017. Shortly after, on August 1, 2017, FDA released the Digital Health Innovation Action Plan, which included plans for the Precertification Pilot program. The program was one of several initiatives outlined by the Agency in the Plan, which was focused on the need for a unique framework for the regulation of digital health software. Commissioner Gottlieb noted that FDA needed to update its approach to regulating products that require continuous revisions and upgrades so that FDA regulation “fosters, not impedes, innovation.” He noted that any regulatory framework for software must accommodate “the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

On September 26, 2017, after outlining the Pre-Cert Program proposal in FDA’s Digital Health Innovation plan, FDA selected nine software companies for its pilot program: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. The following month, FDA released its initial “Software Precertification Program Model.” On April 26, 2018, FDA published the Pre-Cert Working Model, which was next updated on June 19, 2018, before being reformulated into the “Working Model 1.0” version published this month.

Issuance of these two documents was the final step before implementation of the Pilot Program. As noted, nine companies were selected in 2017 to assist with the development of the Pre-Cert Program, and those companies will now participate in the Program’s piloting. Those companies and stakeholders not participating in the Pilot are still highly encouraged to become involved in the iterative process that FDA is using to develop the Program. For example, FDA has been publishing “incremental versions” of the working model with the intention that the public provide feedback on the open docket, which will be reviewed every two weeks (the docket is available here). FDA plans to review all comments submitted to this docket before March 8, 2019.

Pre-Cert Working Model Version 1.0

The Pre-Cert Working Model is a document intended to implement the Software Pre-Cert Pilot Program. Full implementation of the proposed software regulations may ultimately require further statutory authority. The program is envisioned as a voluntary pathway with a more streamlined and efficient review process for approving or clearing software-based medical devices from manufacturers who have “demonstrated a robust culture of quality and organization excellence (CQOE) and are committed to monitoring real-world performance.”

The first version of the model was issued in early October 2017, and there have been four iterations of the document:

1. The initial “Software Precertification Program Model” (Oct. 2017);

2. “Developing a Software Precertification Program: A Working Model” (Apr. 26, 2018);

3. “Developing Software Precertification Program: A Working Model” (i.e., the update) (June 19, 2018); and

4. The current “Developing a Software Precertification Program: A Working Model (Version 1.0)” (Jan. 2019).

The current Working Model 1.0 envisions an approval process in which software applicants are eligible to utilize different approval pathways based on whether they have been “FDA pre-certified.” Pre-certified software will be processed through a streamlined premarket review cycle and then commercially distributed. Notably, the review cycle will not end with distribution; according to the current model, real-world data collection will continue, based on real-world evidence, patient preference, clinical trials, and regulatory science. This data will be fed back into the cycle to help assess product effectiveness and, ideally, allow for a system that upgrades and updates the product. Version 1.0 focuses on evaluating organizations and their software as a medical device (“SaMD”) products throughout the entire lifecycle of the products and the organization, i.e., throughout the “Total Product Lifecycle” (or “TPLC”).

Version 1.0 outlines the process by which companies will be pre-certified based on their culture of quality and organizational excellence (“CQOE”). This cultural assessment will be based on the following “excellence principles”:

  • Product Quality—Demonstration of excellence in the development, testing, and maintenance of SaMD products necessary to deliver the highest quality SaMD products.
  • Patient Safety—Demonstration of excellence in emphasizing patient safety as a critical factor in all decision-making processes and providing a safe patient experience.
  • Clinical Responsibility—Demonstration of excellence in responsibly conducting clinical evaluation and ensuring that patient-centric issues, including labeling and human factors, are appropriately addressed.
  • Cybersecurity Responsibility—Demonstration of excellence in ensuring cybersecurity and proactively addressing cybersecurity issues through active engagement with stakeholders and peers.
  • Proactive Culture—Demonstration of excellence in a proactive approach to surveillance, assessment of user needs, and continuous learning.

Any organization that intends to develop or market software that is defined as a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) will be permitted to apply for precertification under the Software Pre-Cert Program.

Like previous versions of the Pre-Cert Working Model, Version 1.0 includes release notes, which detail changes that were made from the previous version. Version 1.0 has made the following changes since the previous iteration:

  • Section 3 now includes a “description of the Total Product Lifecycle approach.”
  • Section 4 has revised descriptions for levels of precertification and clarified that FDA intends to be primarily responsible for all Excellence Appraisals during 2019 program testing.
  • Section 5 includes revisions to “Software as a Medical Device Product-Level Elements.”
  • Section 6 has updated the “streamlined premarket review process,” proposed a list of review elements for streamlined review, and provided a description of the proposed review elements.
  • Section 7 has updated the description of the process for developing a “real-world performance analysis,” including new examples of real-world performance analytic types and sources and new examples illustrating how the types of real-world performance analytics (as well as the duration of the collection of various types of analytics) may vary based on the intended purpose of their use.

Notably, these modifications to the model were largely made in direct response to comments submitted by stakeholders on the previous version of the document (such commentary is summarized in the Section 9 Appendix of Version 1.0), demonstrating FDA’s willingness to accept and incorporate feedback from industry and other stakeholders.

Pre-Cert 2019 Test Plan

The Pre-Cert 2019 Test Plan is intended to “assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for an SaMD product prior to its introduction to the market, as compared to the traditional paradigm.” The Test Plan effectively establishes a procedure by which both the new, precertification model proposed in Version 1.0 and traditional approval processes are applied to each test case to allow for direct comparison of the outcomes and the bases for decision-making.

To do so, FDA will test the Working Model Version 1.0 with a mock streamlined review package for selected premarket submissions. After conducting Excellence Appraisals, certain submissions will be offered the “Pre-Submission” pathway to approval, as proposed in the Working Model. Each such submission will be reviewed by an independent review team at FDA’s Center for Devices and Radiological Health (“CDRH”), which will evaluate whether it has sufficient information from the Excellence Appraisal elements to reasonably assure the safety and effectiveness of the product. Meanwhile, the product will also be submitted to CDRH for approval through traditional pathways—De Novo or 510(k), as appropriate. Any information that is missing from the mock Pre-Submission pathway and is deemed necessary for appraising the product will be “unmasked” from the traditional submission.

FDA has not opened a public docket to accept comments on the test plan; however, there are several alternative avenues available to industry to raise concerns with FDA related to the Plan.

Pre-Cert Regulatory Framework for Conducting the Pilot Program

The Regulatory Framework document “lays out how the FDA will implement the Pilot Program within its current authorities.” According to the document, FDA intends to draw authority for the software Pre-Cert Pilot Program from the De Novo classification process outlined in Section 513(f)(2) of the FD&C Act. The existing De Novo classification process allows low to moderate risk devices to obtain marketing authorization as Class I or II devices, thus exempting them from the Class III requirement for premarket approval. FDA intends to use SaMD products that would be eligible for De Novo review as participants in the pilot.

FDA argues that the elements of the “Excellence Appraisal” correspond to the control requirements of the Quality System Regulation (“QSR”) and the De Novo review process. As noted above, products given an “Excellence Appraisal” via the Working Model Version 1.0 will also be submitted to the traditional De Novo or 510(k) application processes during the pilot phase. FDA intends to use this same legal theory to allow for future testing of the TPLC approach to the Pre-Cert program.

While FDA claims that its De Novo and 510(k) authorities provide authorization for the Pre-Cert Pilot Program, it is not clear whether these authorities will continue to support streamlined review after completion of the pilot program when proposed devices are no longer being reviewed through both tracks in parallel. As FDA noted in Working Model Version 1.0, it is possible that additional legislation will need to be enacted in order to grant FDA full authority to implement the final plan. As with the Test Plan, the Agency has not provided a public docket for stakeholder feedback on this document.


The proposed new “Pre-Certification Program” has the potential to offer manufacturers of SaMD products a faster route to FDA approval, provided they have a history of “excellent” product quality and safety, conduct clinical research responsibly and practice good cybersecurity hygiene, and engage in proactive self-assessment and self-surveillance. It is unclear yet how widely the Pre-Cert Program may ultimately apply, but FDA intends for it to be applicable to—and tailor made for—software devices. For the time being, the application process will incorporate both the new Pre-Cert Working Model (for the limited group of nine preselected firms) and traditional means of review. FDA has indicated a strong interest in industry input. King & Spalding would be happy to assist you in drafting and submitting comments to FDA. Such comments must be submitted to the Agency before March 9, 2019.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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