Medical Devices

Precertification (Pre-Cert) Pilot Program: Frequently Asked Questions

Precertification Questions

1. What are the criteria that the FDA is planning to use to pre-certify a company?

The criteria are still being developed. The FDA is currently basing the criteria on five excellence principles: patient safety, product quality, clinical responsibility, cybersecurity responsibility, and proactive culture. The FDA is considering evaluating Key Performance Indicators for each principle.

2. What would it mean to be pre-certified?

The Software Pre-Cert Program would pre-certify organizations, not individual products. Although details related to the precertification of an organization and regulatory benefits are being developed, we envision that a precertified organization would be able to benefit from a streamlined program that would allow faster time to market for their products and leverage real world performance to proactively meet user needs by responsibly iterating. The goal of our envisioned approach is for the FDA, after reviewing systems for software design, validation, maintenance and performance monitoring, to determine whether the company has a culture of quality and organizational excellence. Because the precertification process would give the FDA assurance that the organization produces, or could produce, high-quality, safe, and effective SaMD, precertified organizations could potentially submit less information in a marketing submission for a new digital health product. In some cases, a precertified organization may not be required to submit a premarket submission. In those cases, the precertified organization could launch a new product and immediately begin postmarket data collection and performance monitoring. The postmarket data could help the FDA assure that the new SaMD remains safe and effective as well as support new uses.

3. Would the FDA have various levels of precertification?

For the pilot program, 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 a SaMD and/or medical devices.

4. How will an organization know if it has been pre-certified?

The FDA will notify a company that it has been pre-certified. The FDA expects to provide as much information to the public on the Software Pre-Cert Program as possible while respecting confidential commercial information. Participation in this pilot will not directly result in being precertified. Participants in the current pilot will need to meet the same requirements as other companies that might apply when the program is expanded.

5. What are ways the FDA is planning to decide if a company can keep its precertification status?

The FDA expects that precertified organizations would share with the agency information that supports the appraisal related to the excellence principles. Precertified organizations would be expected to respond appropriately to postmarket indicators, including adverse events, to ensure the continued safety and effectiveness of their devices. The FDA is also considering monitoring how organizations track results and trends related to the excellence principles to ensure a continued culture of quality and organizational excellence.

6. When do you expect to announce which companies have received precertification?

The FDA cannot speculate at this time when the first participants might complete precertification. At this stage, we are still exploring and evaluating elements and processes that might be appropriate for a future Precertification Program. The FDA’s goal is to establish the framework of Pre-Cert 1.0 by the end of 2018, and have a limited number of organizations precertified in 2019.

7. Will industry be able to self-certify?

At this time, it is too early to address the question of “self-certification”. The current goal is to explore leveraging third parties to perform certification to assure that independence and objectivity in the certification is maintained to a criteria and standard developed collaboratively with all stakeholders.

8. Can an organization be pre-certified if it is not in compliance with applicable FDA regulations?

The FDA will hold pre-certified organizations to the same compliance standards the agency expects from all companies regulated by the FDA.

9. Would the FDA use third-party certification for software precertification?

The criteria developed and evaluated for precertification during the pilot program may also be used to inform the establishment of a third-party software precertification program, in which third parties may help facilitate the precertification of organizations. Among other benefits, this could allow the agency to focus more of its resources on the evaluation of higher risk technologies/products.

Currently, the FDA is exploring leveraging accredited third party organizations to conduct the appraisals, as well as the capability to demonstrate excellence through a fully data and measures driven process. The Pilot Program will also help FDA identify the criteria for precertification that could help it develop the boundaries of a third-party review that is aligned with FDA's mission to protect the public health.

10. How will the FDA evaluate companies that have a wide range of business arms?

Our current thinking is that precertification would apply to a business unit, but we welcome stakeholder input on the issue. These concepts will be considered during the pilot. Impact on company acquisitions will also be considered.

11. Would organizations get credit for compliance with other industry standards and accreditations (e.g., security certifications)?

The FDA expects the Software Pre-Cert Program would allow organizations to leverage existing certifications or evaluations demonstrating conformance with best practices and/or recognized industry standards.

12. How will the FDA ensure that precertification reduces burden instead of adding to it?

In addition to leveraging existing certifications or evaluations, the FDA aims to develop a program that allows organizations to maintain the customized processes they already use to create and maintain a culture of quality and organizational excellence. The goal for organizations is to spend minimal resources translating what they do to the FDA’s regulatory framework.

13. How will the FDA ensure the KPIs it selects are applicable to the variation in processes and metrics across companies?

The FDA recognizes that no one set of KPIs will work for all firms, given the diversity of organizations in the digital health space. The FDA intends to explore, along with stakeholders, an option to develop a library of KPIs that can be selected among, based on the specific business and organizational structure of the entity, to demonstrate a culture of quality and organizational excellence.

14. How will the Software Pre-Cert Program be flexible enough to accommodate differences in sub-cultures within an organization, or the effect of individual people in small cultures?

The FDA is seeking stakeholder input on this issue. Our current thinking is that organizations with a culture of quality and organizational excellence have processes and structures in place to ensure that whatever variability exists across the organization does not undermine or jeopardize that culture of quality or organizational excellence.

Premarket Review Questions

15. Once an organization is pre-certified, how long would it take to get a product approved or cleared?

Because the precertification process would give FDA assurance that the organization produces high-quality, safe, and effective products, the FDA is exploring whether precertified organizations may potentially submit less information in a premarket submission than is currently required before marketing a new digital health tool. In some cases, such as for low-risk products, precertified companies might not submit a premarket submission at all. The goal is for a precertified organization to be able to get products to market faster, in general, than they would if they were not precertified.

16. How does clinical evaluation apply to these products?

The requirements for conducting an assessment and analysis of a SaMD’s clinical safety, effectiveness, and performance as intended by the SaMD manufacturer are unchanged. The SaMD must still be substantially equivalent or have a reasonable assurance of safety and effectiveness, although demonstration of this does not necessarily require a clinical investigation/study. Please refer to the Software as a Medical Device (SaMD): Clinical Evaluation final guidance.

17. Will updates or modifications to software be launched more easily for a pre-certified organization?

The FDA envisions allowing precertified organizations to make certain product iterations easily by proactively addressing safety issues. Through the pilot, the FDA is exploring tailored pathways for more efficient ways for precertified organizations to update or modify their SaMD. We are looking for input from stakeholders about the appropriate role of FDA in overseeing updates or modifications to software from precertified organizations.

18. Will precertified organizations need to go through the Q-submission process?

The current Q-submission process is intended to assist companies during the development and review of their products. The FDA has not yet determined the details of a streamlined premarket review processes for the Pre-Cert Program. We are exploring various approaches, including whether a process similar to the Q-submission process would help align expectations to facilitate both timely development and review of products from precertified organizations.

19. Can pre-certified organizations get a "concierge service" within the FDA to facilitate a smoother FDA review experience, reducing regulatory uncertainty?

The FDA's working framework for the Software Pre-Cert Program would reduce burden for individual product review by streamlining premarket submission requirements or potentially eliminating premarket submissions for certain devices. We welcome input from stakeholders on potential benefits of the program that would add value, balance resources and align with the FDA's objectives.

Real-World Data and Performance Questions

20. What types of real-world performance data would the FDA expect from organizations that are precertified?

Postmarket data collection is the likely fourth component of the pilot program. One exciting feature of software is the ability to collect a range of postmarket data more easily than traditional, hardware-based devices. We envision using postmarket data to monitor the safety, effectiveness, and performance of SaMD in the field, monitor precertification status, and to support future uses. We look forward to collaborating with the public to design the key elements of this program to fulfill both the needs of software developers and the agency's public health mission, including postmarket data collection. We hope to determine through the pilot the types of postmarket data most useful in ensuring consumers are receiving safe and effective products, and how this data should be collected if it is being used to support regulatory decisions. This real-world evidence would likely be part of the National Evaluation System for health Technology (NEST), which would generate better evidence for medical device evaluation and regulatory decision-making throughout the device innovation cycle.

21. How will inspections be conducted for precertified organizations?

We envision that the precertification process should give the FDA assurance that the organization produces high-quality, safe, and effective devices. As we gain more experience, the FDA intends to leverage this assurance to determine the role of inspection for a pre-certified organization.

General Questions

22. Why is the FDA trying to develop a new regulatory approach for software as a medical device?

For Americans to see the full benefits of digital health products, we need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, and the compressed cycle of product iterations.

The FDA's traditional approach to medical devices is not well-suited to these products. A new, pragmatic approach that recognizes the unique characteristics of digital health technology and the marketplace for these tools can promote the public health by supporting the innovation of high-quality, safe, and effective digital health devices. More information about software as a medical device can be found on FDA's Software as a Medical Device webpage.

23. Why is the FDA doing the pilot?

The FDA is developing our program with the input from public comments, which we believe can help the program to be successful and achieve our commitment to public health. The FDA is learning from the pilot participants, the public, and the input from the public workshop held on January 30-31, 2018. The FDA is now looking for further input on key aspects of the program.

24. Is the FDA committed to this Pilot Program and new approach to digital health?

Yes. This pilot is important and is a priority for the agency. The Software Pre-Cert Program is reflective of the FDA's commitment to promoting the public health by fostering innovation, allowing patients to experience the benefits of advances in software development by facilitating access to high quality, safe, and effective digital health products.

25. Are FDA review staff aligned with this program?

The Digital Health Team has been working with FDA staff since the inception of the program to hear valuable staff feedback regarding the program. The FDA staff with many relevant responsibilities and expertise, including product reviews, are engaged in the process.

26. How would consumers benefit from this pilot?

We believe streamlining the regulatory review process will help encourage innovation of digital health technologies. This innovation, and the associated rapid iterative cycles have the potential to improve patient outcomes and product performance.

27. How will this program move from Pilot Program to a permanent program? Will it require new regulations and/or legislation?

This pilot is an important first step to help us explore and evaluate the program model to inform how we establish the Precertification Program. Once we determine the elements necessary for a future Precertification 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.

28. How can I stay informed about Software Precertification Pilot Program?

For updates on the Pre-Cert program, you can:

Page Last Updated: 06/19/2018
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