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  5. Precertification (Pre-Cert) Pilot Program: Frequently Asked Questions
  1. Digital Health Software Precertification (Pre-Cert) Program

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

The Software Precertification (Pre-Cert) Pilot Program will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices. This pilot, limited to manufacturers of software as a medical device (SaMD), is an important first step to help us explore and evaluate the program model to inform how we establish the Pre-Cert Program.

General Questions

1. Is the Pre-Cert Program voluntary?

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

2. How can I be involved in the Pre-Cert Pilot Program if the FDA has already chosen the pilot participants?

The FDA continues to seek public feedback on Pre-Cert. 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. 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 relevant responsibilities and expertise, including product reviews, are engaged in the process.

4. 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.

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

The Pre-Cert Pilot Program's current working model (PDF) explains how the FDA has reimagined its way of regulating digital health products. The accompanying Regulatory Framework document (PDF) explains how the FDA plans to implement the Pre-Cert Pilot Program within the 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 Pre-Cert 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 (PDF). The 2019 Test Plan (PDF) summarizes how the FDA will test the model in 2019 with certain SaMD De Novo Requests and 510(k) submissions from test pilot participants.. And internally, we will use selected previously-reviewed SaMD submissions to evaluate how well the Pre-Cert model produces an equivalent basis for determining reasonable assurance of safety and effectiveness for a SaMD product prior to its introduction to the market, as compared to the traditional model.

Precertification Questions

6. 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.

7. 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.

8. What would it mean to be precertified? What is the anticipated benefit of the program?

The Software Pre-Cert Program would pre-certify organizations, not individual products. Although details related to the precertification of an organization are being developed, we envision that a precertified organization would be able to benefit from a streamlined submission 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 is capable of producing, 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, the FDA envisions that, for some SaMD 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, thus enabling timely access for patients to high-quality products. The postmarket data would help the FDA assure that the new SaMD remains safe and effective over the product lifecycle.

9. Would the FDA have various levels of precertification?

For the future state of the program, the FDA is currently considering the possibility of 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 or medical devices.

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

For the future state of the program, the FDA would communicate the organization's precertification status at the end of the appraisal. Currently, the FDA aims to complete an Excellence Appraisal within five days of its initiation

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.

11. 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. As outlined in the section 3.6 of the version 1.0 working model (PDF), several factors (for example, organizational restructuring or incorporation of a new clinical domain not previously assessed) may trigger the need for an additional Excellence Appraisal, in addition to other requirements under the FD&C Act or its implementing regulations.

12. 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 Pre-Cert 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.

13. 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 criteria developed collaboratively with all stakeholders.

14. 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.

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

The FDA's vision for the future of the Software Pre-Cert 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 the 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.

16. 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.

17. Would organizations get credit for compliance with other industry standards and accreditations (for example, security certifications)?

The FDA expects the Software Pre-Cert Program could allow organizations to leverage existing certifications or evaluations demonstrating conformance with recognized industry standards provided that the applicable statutory standards are met.

18. 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 is to develop a least burdensome approach for organizations is to spend minimal resources translating what they do to the FDA's regulatory framework.

19. 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.

20. 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.

21. After a company has participated in an Excellence Appraisal, would all the company’s future SaMD submissions from the Excellence Appraised organizational unit of that company be able to leverage the device master file from the completed appraisal?

For the duration of the 2019 Test Plan, SaMD submissions received from Excellence Appraised companies will continue to be traditional marketing submissions that include all required elements of the submission type. During the 2019 testing, if an Excellence Appraised company has multiple submissions that are included in the Test Plan, the FDA would not conduct another full Excellence Appraisal, but would instead re-purpose information documented during the original appraisal.

After the Test Plan is completed and the FDA is confident that the regulatory requirements for making a determination of reasonable assurance of safety and effectiveness are satisfied through the combination of the Excellence Appraisal and a Streamlined Review process, the FDA intends to move forward as described in the Regulatory Framework document issued in January 2019. The FDA would conduct an Excellence Appraisal based on the final model and would allow Excellence Appraised companies to submit streamlined Pre-Cert submissions that would leverage information in device master files documented during the Excellence Appraisals.

22. Will all CDRH offices and divisions reviewing SaMD submissions for Excellence Appraised companies accept the Streamlined Review process, which would leverage the device master file from completed appraisals?

The scope of the future Pre-Cert program will include SaMD submissions of varying technologies and uses, so that companies who have been Excellence Appraised will be able to leverage the appraisal for SaMD submissions reviewed by any CDRH office or division. Throughout the development of the Pre-Cert program, the Pre-Cert team is working with CDRH review staff to develop appropriate processes and oversight to ensure appropriate implementation and adoption of the Pre-Cert approach.

Premarket Review Questions

23.Once an organization is precertified, how long would it take to get a product approved or cleared?

Because the precertification process would give the 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 should be able to get products to market faster, in general, than they would if they were not precertified.

24. How does clinical evaluation apply to these products?

The statutory and regulatory 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.

25. Will updates or modifications to software be launched more easily for a precertified organization?

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 the FDA in overseeing updates or modifications to software from precertified organizations.

26. 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 the Q-submission process or similar process would help align expectations to facilitate both timely development and review of products from precertified organizations.

27. Can precertified organizations get a "concierge service" within the FDA to facilitate a smoother FDA review experience, reducing regulatory uncertainty?

The FDA's working model 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

28. 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 SaMD 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 SaMD 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.

29. 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.

2019 Test Plan Questions

30. During the 2019 Testing of the Pre-Cert approach, as outlined in the 2019 Test Plan, will the same review team evaluate the mock Streamlined Review package as well as the traditional regulatory submission?

For each submission in the 2019 Test Plan, the evaluation of the mock Streamlined Review package and the traditional regulatory submission will be conducted by a review team with appropriate expertise to the device type and Pre-Cert program. The review team will first review the mock Streamlined Review package. Subsequently, the review team will evaluate whether it can make a regulatory decision on the mock package, before unmasking the traditional regulatory submission, upon which the official regulatory decision will be based.

31. Do the test cases included in the 2019 Test Plan need to be submitted, reviewed, and decided in 2019, or might some test cases be submitted in 2020?

The FDA is interested in conducting Excellence Appraisals with SaMD sponsors who expect to submit traditional marketing submissions in 2019, or shortly thereafter, to inform the development of the Pre-Cert program as the FDA seeks to validate the Software Pre-Cert Pilot program. The FDA intends to review test cases in 2019, as resources permit, to meet the goals of the 2019 Test Plan during the calendar year. However, the FDA understands that some Pilot Participant submissions and other test cases may not be completed in 2019, and the FDA will do our best to accommodate timelines, as necessary.

32. Will De Novo submissions that are part of the 2019 Test Plan be used to establish special controls for the Pre-Cert program?

De Novo submissions that are reviewed during the testing of the Pre-Cert approach will not lead to the establishment of special controls for Excellence Appraisal elements or other aspects of the proposed Pre-Cert program. The 2019 Test Plan will be completed before such special controls are established, because the FDA first needs to determine that the totality of evidence collected through the Excellence Appraisal and Streamlined Review processes align to and satisfy the regulatory requirements for making a determination of reasonable assurance of safety and effectiveness.

33. After the FDA proceeds to the De Novo Pathway outlined in the Regulatory Framework, will the special controls that are established include organization-level metrics or other Excellence Appraisal elements? How would such special controls apply to follow-on SaMD products that seek 510(k) clearance under the classification created by the De Novo order?

As outlined in the Regulatory Framework, the FDA intends to create appropriate special controls that may be satisfied by Excellence Appraisal for organizations who opt to pursue certification, or by data that would be submitted as part of the follow-on 510(k) for organizations who opt not to pursue certification. Examples of the types of special controls that might be utilized include: meeting certain Excellence Appraisal elements or requirements for notifying the FDA if certain appraisal elements are changed after the Excellence Appraisal is conducted or postmarket data collection requirements as deemed necessary for the device type; or change protocols that may permit certain modifications to the device without premarket review when the special controls effectively mitigate risks associated with such modifications. The FDA’s intention is that the special controls could be met either through participation in Pre-Cert or by other means. Therefore, a developer of a SaMD of the same device type would not need to submit a new De Novo Request, because the De Novo order that establishes certain Pre-Cert elements as special controls could serve as the predicate device for SaMD products, whether or not the developer is pursuing the Pre-Cert approach.

34. When will participating companies be able to realize the benefits of the Pre-Cert approach, including Streamlined Review of marketing submissions and marketing of modifications?

Companies participating in the 2019 Test Plan are helping the FDA iterate and confirm that the framework proposed in the Working Model provides a reasonable assurance of safety and effectiveness for software products. These companies will participate in Excellence Appraisals, but the FDA does not intend to provide precertification for companies during the testing in 2019.

After the completion of the 2019 testing, the FDA anticipates that companies who participate in the Pre-Cert program and submit De Novo Requests for SaMD products will realize benefits that would be established via special controls for those products, including Streamlined Review of SaMD submissions and the ability to market modifications that are mitigated effectively by the special controls, which may include Excellence Appraisal elements and postmarket real-world performance requirements, as appropriate.

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