Medical Devices

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

General Questions

1. Is the Pre-Cert program voluntary?

The Software Precertification Program is envisioned as a voluntary pathway that embodies a regulatory model more tailored than the current regulatory paradigm to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.

2. How can I be involved in the Software Precertification Pilot Program if the FDA has already chosen the pilot participants?

The FDA is seeking public feedback on this version of the working model by March 8, 2019, at https://www.regulations.gov/comment?D=FDA-2017-N-4301-0001. This feedback will be incorporated into future versions of the program model, which will also be disseminated for public input. The FDA intends to consider stakeholder comments by reviewing the public docket approximately every two weeks, and to incorporate comments, as appropriate, in future versions of the working model. We encourage the public to provide feedback early and often.

3. 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 the FDA's Software as a Medical Device webpage.

4. 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.

5. 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.

6. How would patients 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. While the FDA’s goal with Pre-Cert is to regulate digital health technologies in a way that fosters innovation, the model the agency is piloting is firmly rooted in protecting patient safety.

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

The Software Precertification Pilot Program (Pre-Cert)’s current working model explains how the FDA has reimagined its way of regulating digital health products. The accompanying Regulatory Framework document explains how FDA plans to implement the Pre-Cert Pilot Program within FDA’s current regulatory authorities. This next phase of the pilot is an important first step to help us explore and evaluate the program model to inform how we establish the Precertification Program. The FDA’s latest working model details the key components of the Pre-Cert pilot program. Learn more about the regulatory framework for the Pre-Cert model. The 2019 Test Plan summarizes how the FDA will test the model in 2019 with certain SaMD De Novo Requests from Pre-Cert pilot participants and internally using selected previously-reviewed SaMD submissions in order to evaluate how well the Pre-Cert model produces an equivalent basis for determining reasonable assurance of safety and effectiveness for a software as a medical device product prior to its introduction to the market, as compared to the traditional paradigm.

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

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

Precertification Questions

9. When will the FDA be precertifying companies?

The FDA is still developing the Pre-Cert pilot program and will not be “precertifying” companies in 2019. The FDA will be conducting Excellence Appraisals with pilot participants and leveraging information collected during the appraisals for those companies’ premarket submissions.

10. What are the criteria that the FDA would use to precertify 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.

11. What would it mean to be precertified?

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 a future state of the program, FDA envisions that for some products, 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.

12. Would the FDA have various levels of precertification?

For the future state of the 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.

13. How would an organization know if it has been precertified?

The FDA will notify a company that it has been precertified. The FDA expects to provide as much information to the public on the Software Pre-Cert Program as possible while protecting confidential commercial and trade secret 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.

14. What are ways the FDA would 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.

15. When would 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 released the Pre-Cert 1.0 working model, and will be testing the Pre-Cert framework, including conducting excellence appraisals, with a limited number of organizations in 2019.

16. 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.

17. Can an organization be precertified if it is not in compliance with applicable FDA regulations?

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

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

The FDA’s vision for the future of the Software Precertification Program includes the identification and accreditation of third parties with the capacity and expertise to conduct an excellence appraisal and who would perform the Excellence Appraisals for organizations seeking precertification. The appraisal information collected by third parties would be used as information in FDA’s regulatory decision making, similar to a conformity assessment of an FDA recognized consensus standard. Learn more about Third-Party Appraisers in the Pre-Cert working model.

19. 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.

20. Would organizations get credit for compliance with other industry standards and accreditations (for example, 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.

21. How would 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.

22. How will the FDA ensure the Key Performance Indicators (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.

23. 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

24. Once an organization is precertified, 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, because organization-level information would have already been assessed during the Excellence Appraisal. In a future state of the Pre-Cert program, in some cases, such as for low-risk products, precertified companies might not submit a premarket submission at all. Because the precertified organization would have already been evaluated for its ability to produce safe and effective products, a precertified organization to be able to get products to market faster, in general, than they would if they were not precertified.

25. 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.

26. Will updates or modifications to software be launched more easily for a precertified 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.

27. 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.

28. Can precertified 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. During the next phase of the program in 2019 we will test how best to facilitate an enhanced review experience.

Real-World Data and Performance Questions

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

While specific real-world performance data elements and analytic methodologies may differ across organizations and product categories, excellent organizations consistently collect and analyze post-market (post-launch) data from diverse sources to inform their operations and decision making, from quality control to product development for new market segments. We envision that precertified organizations would select specific data elements within the proposed framework based on the intended use, functionality, and risk classification of the software as a medical device product. During Excellence Appraisal, all precertified organizations would demonstrate the capability to collect and analyze post-launch real-world performance data, whether by instrumenting their software as a medical device to generate needed data, or by leveraging alternative data sources. Learn more about real-world performance data and analytics in the Pre-Cert working model.

30. 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 precertified organization.

Page Last Updated: 01/07/2019
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