Medical Devices

Digital Health Software Precertification (Pre-Cert) Program

What Is the Software Pre-Cert Pilot Program?

The Software Precertification (Pre-Cert) Pilot Program, as outlined in the FDA's Digital Health Innovation Action Plan [PDF], will help inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.

The FDA envisions that the future regulatory model will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market. This proposed approach aims to look first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for traditional medical devices.

Because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, the FDA is working to establish a regulatory framework that is equally responsive when issues arise to help ensure consumers continue to have access to safe and effective products. In the Pre-Cert program, the FDA is proposing that software products from precertified companies would continue to meet the same safety and effectiveness standard that the agency expects for products that have followed the traditional path to market.

This pilot is an important first step to help us explore and evaluate the program model to inform how we establish the Pre-Cert Program. Once we determine the elements necessary for a future Pre-Cert Program, we will then look towards the appropriate mechanisms for establishing the program, including an assessment of the FDA's current statutory and regulatory authorities.

Pre-Cert 1.0, the first version of the program with a goal that it will be available for pilot testing within FDA's current authorities in 2019, is limited to manufacturers of software as a medical device (SaMD). As the FDA leverages insights from testing of Pre-Cert 1.0, the agency envisions offering the voluntary program to manufacturers of software in a medical device (SiMD), and other software that could be considered accessories to hardware medical devices.  The FDA will be guided by the definition of software as defined in section 201(h) (as amended by section 520(o)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in developing the program. 

The term Software as a Medical Devicedisclaimer icon is defined by the International Medical Device Regulators Forum (IMDRF) as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. More information about how a SaMD is defined is available in the International Medical Device Regulators Forum (IMDRF) guidance documentsdisclaimer icon and the finalized SaMD clinical evaluation guidance document.

How Does the Pre-Cert Pilot Program Work?

The FDA is identifying key program components for the pilot program that builds on the initial concept identified in the FDA's Digital Health Action Plan. More information about each part of the program is available in the latest Program working model.

Download the Working Model of the Program

The FDA plans to build and iterate the program working model based on input the agency receives from all stakeholders through the public docket throughout the pilot's development phase.

Proposed Key Components:

Excellence Appraisal and Determining Precertification Level: Identifying the objective criteria and methodology that the FDA will use to pre-certify a company and decide whether a company can keep its precertification status.

The FDA is currently basing the Pilot Program's criteria on five excellence principles: patient safety, product quality, clinical responsibility, cybersecurity responsibility, and proactive culture. The FDA is currently considering two levels of precertification based on how a company meets the excellence principles and whether it has demonstrated a track record in delivering software products.

Review Pathway Determination: Developing a risk-based framework so that a precertified company can determine the premarket review pathway for their products. Potentially precertified companies could market their lower-risk devices without FDA premarket review or only a streamlined premarket review based on the company's precertification level and International Medical Device Regulators Forum (IMDRF) risk categorization.

The FDA is planning to leverage the IMDRF framework in determining the risk categorization of a SaMD product, incorporating information about the medical purpose of the SaMD and the seriousness of the medical condition that the SaMD is intended to treat.

The FDA is also considering appropriate means to educate patients and providers about the premarket review and postmarket monitoring obligations for each SaMD risk category.

Streamlined Premarket Review Process: Identifying the type of information that a precertified company would include in its premarket submission for the FDA to review software products for safety and effectiveness before patients access them.

The FDA is exploring using an interactive streamlined review of a SaMD with information the agency already has gained from the process to precertify a company, and additional information the company would share about the SaMD's product performance, clinical association between the SaMD output and a clinical condition, and safety measures.

Monitoring Real-world Performance: Identifying the type of information that a precertified company may have access to about how its software product is performing with patients to support the regulatory status of the product and new and evolving product functions.

The FDA is considering how best to work with a company to collect and interpret real-world information about a SaMD and to evolve the product's safety and effectiveness to address any emerging risks. The sources of real world performance data may include information about a user's experience, software performance data, and clinical outcomes.

What is the Goal of the Pre-Cert Pilot Program?

The goal of the program is to have tailored, pragmatic, and least burdensome regulatory oversight that assesses organizations (large and small) to establish trust that they have a culture of quality and organizational excellence such that they can develop high quality SaMD products, leverages transparency of organizational excellence and product performance across the entire lifecycle of SaMD, utilizes a tailored streamlined premarket review, and leverages unique postmarket opportunities available in software to verify the continued safety, effectiveness, and performance of SaMD in the real-world.

The Software Precertification (Pre-Cert) Program's aims are to:

  • Benefit a participating organization based on its "precertified" status by offering the ability to market lower risk software as a medical device (SaMD) without premarket review of individual products, or participate in a streamlined premarket review and opportunities to collect and leverage real-world postmarket data.
  • Leverage and use information and data from all available sources allowing FDA and SaMD manufacturers to be more efficient and streamlined without compromising safety and effectiveness of SaMD products.
  • Enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion.
  • Ensure high-quality software products throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organizational excellence.
  • Adapt key elements and measure based on the effectiveness of the program.

Who Is Currently Involved in the Pre-Cert Pilot Program?

In September 2017, the FDA selected nine companies out of over 100 applicants to participate in the development of the Software Pre-Cert pilot program:

  • Apple
  • Fitbit
  • Johnson & Johnson
  • Pear Therapeutics
  • Phosphorus
  • Roche
  • Samsung
  • Tidepool
  • Verily

The details of selection criteria for the pilot program were published in the Federal Register notice Software Precertification Pilot Program.

The FDA also hired three Entrepreneur-in-Residence fellows to help support the development of the Pre-Cert Program.

How You Can Get Involved with the Pre-Cert Pilot Program

The FDA encourages your feedback on the pilot phase of the Pre-Cert Pilot Program and the following challenge questions using the links below. Although the challenge questions are organized by the Pilot Program components, the questions should be considered in coordination with all aspects of the Software Precertification Pilot Program as described in the most recent version of the working model.

Your input will help shape the next steps that we take to build the program. The FDA also encourages stakeholders to self-organize as groups and provide consolidated feedback.

These questions are part of a comprehensive list which may be downloaded using the link below.

Download the Full List of Challenge Questions

Excellence Appraisal and Determining Precertification Level questions:

  • How might an existing excellence or maturity appraisal framework used by a SaMD manufacturer be leveraged to demonstrate an organization's performance and success as outlined by the five excellence principles?
  • How might the appraisal process consider the track record demonstrated through an organization's objective Key Performance Indicators (KPIs) as part of the evaluation?
  • Does it matter if the track record is in medical device products or in consumer products? How long, and how detailed of a track record would be needed to demonstrate an organization's sustainable performance? Why?
  • When looking at past performance, how should negative events be evaluated to provide an accurate assessment of responsiveness, responsibility, and improvement?
  • The FDA is anticipating establishing two levels of precertification. Please advise whether and why the same appraisal model should be used to assess all organizations applying for precertification, or whether separate appraisal models should be used for each level of precertification.

Review Pathway Determination questions:

  • Given the definition of SaMD, what additional information is needed to help stakeholders clearly differentiate between software as medical device (SaMD), software in a medical device (SiMD), and other types of software and hardware?
  • The IMDRF definition statementdisclaimer icon is intended to provide a structure towards defining intended use. Should other components be included, and if so, what, or should the current components be modified to provide clarity around the function of the SaMD, and if so, how?
  • The IMDRF risk categorization framework disclaimer icon uses and defines "inform," "drive," and "diagnose/treat" to identify the "significance of information provided by SaMD" of how the SaMD is intended to be used. What additional clarity or modifications are necessary within these definitions that will enhance the use of this risk categorization framework?
  • The IMDRF risk categorization framework disclaimer icon uses and defines "non-serious" "serious" and "critical" to identify the "state of health care situation and condition" where the SaMD is intended to be used. What additional clarity or modifications are necessary within these definitions that will enhance the use of this risk categorization framework?
  • How should FDA think about a major change versus a minor change for SaMD, and about how these changes should be handled?

Streamlined Premarket Review Process questions:

  • Given that one goal of this program is to significantly reduce the average premarket review timeline, what would be the best way for pre-certified companies to share product review information with us? Specifically:
    • What specific elements of review could be shifted to the company-specific excellence appraisal (as opposed to the product-specific review)?
    • What are the features of a SaMD product that need to be assessed during device review?
    • What product-specific content would be expected to be reviewed premarket?
    • What specific postmarket real world data could be collected to support the assurance of safety and effectiveness for each product if an element is not reviewed premarket?
    • What updates should FDA require, and at what interval, to provide continuous assurance of safety and effectiveness?
    • Should there be a phased market authorization, where some elements are reviewed premarket and other elements are gathered through real world evidence to support full market authorization? What should happen to products that receive "preliminary" market authorization but fail to provide adequate evidence in the agreed upon timeframe?

Monitoring Real-World Performance questions:

  • As FDA conducts a landscape assessment of existing real world performance data frameworks and use cases, what are important sources of information and stakeholders to include?
  • How can real world performance data surveillance best be designed to support existing standards of safety and effectiveness?
  • What are critical real world performance data elements to be monitored by SaMD manufacturers?
  • Are the definitions for data types underlying real world performance data accurate and comprehensive or do the terms used in this section need to be modified or revised, and the latter, how?
  • From the perspective of a precertified organization, how does real world performance data differ from real world evidence in supporting pre-launch product clearance and post-launch modification product claims?

Submit Formal Comments on this Pilot Program

Submit Specific Questions about the Pilot Program

For more information:


Additional Information

 

Page Last Updated: 09/27/2018
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