On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice. The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan. CDRH also held a webinar on August 1 to provide an overview of the program and answer stakeholder questions.

In an accompanying FDA Voice blog post, Commissioner Gottlieb acknowledged that “FDA’s traditional approach to medical devices is not well suited” to digital health products. The agency is looking to develop a new regulatory framework that “accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

The Pre-Cert pilot program is the agency’s first step in developing the Pre-Cert program that the agency initially announced last month. The Pre-Cert program will replace the agency’s current product-by-product premarket review process with a process to pre-certify software developers who demonstrate sufficient quality performance. Pre-certified developers would be able to market their software devices with no, or streamlined, premarket review. The program is intended to allow manufactures of software devices to get to market faster and have greater flexibility to iterate product design based on real world experience.

To move the Pre-Cert program from concept to implementation, the agency is initiating a pilot program. The goal of the pilot is to leverage input from the participating companies to help the agency establish the appropriate criteria for pre-certification and appropriate review process for pre-certified companies. Thus, participating companies will have a remarkable opportunity to shape the program and the agency’s regulatory approach to digital health products.

The Pre-Cert program’s developer-based approach represents a significant shift from the agency’s longstanding, fundamental approach to regulating medical products on a product or category basis regardless of the manufacturer. We expect that there will be significant interest in the pilot, although FDA will only select nine companies to participate. FDA also strongly encourages companies who do not participate in the pilot to submit feedback through the public docket.

Pre-Cert Program Overview

Under the Pre-Cert Program, FDA will pre-certify digital health developers who demonstrate a culture of quality and organizational excellence based on objective criteria related to software design, development and testing/validation. The pilot program will help FDA establish the relevant criteria, but during the webinar, the agency suggested that this may include assessing key performance indicators across organization resources (e.g., leadership, training, infrastructure), customer experience, internal processes (e.g., engineering, risk management, product support), and learning and growth. These performance measures could support a “score card” focused on the following five elements:

  • Providing a safe patient experience;
  • Being clinically responsible;
  • Delivering highest product quality;
  • Being cybersecurity responsible; and
  • Being proactive versus reactive.

As depicted in the diagram below, pre-certified developers could then qualify to market their devices without premarket review by FDA or with a more streamlined premarket review, depending on the risk of the devices. The streamlined review process will be determined through the pilot, but it could include reduced submission content, faster review of that content by the agency, or both. Where no premarket review is required, FDA would rely on the pre-certification process to demonstrate that the developer’s software and internal processes are sufficiently reliable to eliminate the need for product-specific review by FDA.

FDA also anticipates that pre-certified developers will collect real-world data postmarket, which could be used to help FDA assure that the new product remains safe and effective as well as support new uses for the device (including higher-risk indications). During the webinar, the agency noted that software devices present a unique opportunity to leverage their connectivity and computing power to allow developers to understand how the product is being used and is working in the market.

Pre-Cert Pilot Program

The goal of the pilot program is to learn from participating companies to inform the development of the Pre-Cert program. FDA intends to use the pilot to answer critical questions and develop key components of the Pre-Cert program, including:

  • Pre-certification components — What performance measures should be evaluated as part of the pre-certification criteria? Should there be multiple levels of certification, correlated to the level of risk of the device? What processes should be implemented for companies to obtain and maintain certification?
  • Pathway decision criteria and process — What criteria should the agency use in determining the appropriate pathway? What does a streamlined review look like? What is the appropriate content and format of such submissions?
  • Postmarket evidence collection — When and how should companies collect postmarket data?

Throughout the pilot, the agency hopes to iterate developing the Pre-Cert program parameters, testing and evaluating of those parameters using the experiences of the participants, and refining the program. During the webinar, the agency clarified that participants may not necessarily obtain pre-certification or be eligible for streamlined premarket review through the pilot. Nonetheless, the pilot is a rare and unparalleled opportunity for the participating companies to shape the agency’s regulatory approach to regulating digital health products.

FDA will accept nine companies into the pilot program. The agency intends to select participants who best match the qualification criteria below and reflect the broad spectrum of software developers, including diversity across large and small firms, companies developing low and high risk devices, and traditional device manufacturers and developers new to devices. The agency is looking to select “best in class” companies who have an established track record of success in developing, testing and marketing software products, although the company need not have a history specifically with medical device software.

FDA is moving with remarkable speed to initiate the pilot program. FDA will begin accepting statements of interest immediately (August 1) via e-mail and the pilot program will formally begin on September 1. FDA will enroll participants on an ongoing basis throughout the duration of the pilot. The agency targets three participating companies in the first phase of the pilot

The statement of interest should include agreement to the following selection qualities:

  • The company must be developing, or planning to develop, a product that meets the definition of software as a medical device. Other types of device software are not the focus of the pilot.
  • The company must have an existing track record in developing, testing, and maintaining software products demonstrating a culture of quality and organization excellence measured and tracked by Key Performance Indicators (KPIs) or other similar measures.
  • While participating in the pilot, the company must agree to:
    • Provide FDA access to the quality and organizational measures (e.g., KPIs) and provide information about the firm’s quality management system.
    • Collect real-world postmarket performance data and provide them to FDA
    • Be available for real-time consultations with FDA and site visits from FDA.

The agency is still determining the level of engagement and time commitment that would be involved in participation, which will depend on the agency’s iterative learning throughout the pilot. However, the agency made clear that participating companies should be ready to dedicate resources to actively partnering with the agency to develop the pre-cert criteria and program.

The agency aims to be as transparent as possible regarding the agency’s learning from the pilot, while protecting participant’s confidential and proprietary information. The agency has not yet determined how and what information the agency will share.

Opportunities to Provide Feedback

The Pre-Cert Program the program is still in the very early stages of development, providing stakeholders a significant opportunity to provide important feedback to FDA and to help shape the program. FDA strongly encourages stakeholders that are not enrolled as participants in the pilot to submit comments to FDA via the electronic docket.

FDA also anticipates holding a public workshop in January 2018 to report on the agency’s findings from the pilot. This workshop will provide stakeholders with an additional opportunity to provide comments