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

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General Questions

Q: Is the agency authorizing any products through the Pre-Cert Pilot Program at this time?

A: No products are being authorized through the Pre-Cert Pilot Program at this time—we are currently building, iterating, and testing the framework of the Pre-Cert Pilot Program vision. During this stage, all products that require clearance or approval are proceeding through existing regulatory pathways. In parallel, the agency is testing different approaches internally that may facilitate both timely development and review of products.

Q: What is meant by the term “Pilot”?

A: “Pilot,” as used in the context of the Pre-Cert Pilot Program, is intended to be understood as a pilot exploration, pilot study, or pilot project. This Pre-Cert Pilot Program is meant to explore a reimagined regulatory paradigm that will help determine how to tailor a Total Product Lifecycle approach to oversight of software. The exploration, as highlighted in the Working Model 1.0, is initially examining approaches for the evaluation of Software as Medical Device (SaMD) and the organizations that develop those SaMD to maintain a high level of confidence in these products and to support a reasonable assurance of safety and effectiveness.

Q: How is the FDA conducting the Pre-Cert Pilot Program?

A: In September 2017, the FDA identified nine pilot participant organizations that represent a range of SaMD developers/manufacturers, to help with building out and testing components of the Pre-Cert Pilot Program. In addition to continuing to learn from the nine pilot participants, the Center is also testing with other self-identified volunteers to inform the development of the Pre-Cert Pilot Program. The development roadmap of the pilot program is comprised of several phases: In 2017, the FDA was in the Forming phase, when the initial idea and concept of the Pre-Cert Pilot Program were first envisioned.  In 2018, the FDA began the Modeling phase, during which we further researched the idea and solicited input from stakeholders.  This Modeling phase has continued in 2019 and 2020, as we build, iterate, and test the proposed Pre-Cert Pilot Program framework. The next phase will be the Assessing phase where the FDA will identify infrastructure needs and plans for statutory authority. The FDA plans to follow this with Beta-Testing which will focus on scaling up the testing of the program. And then, the FDA would look to transition from Pilot to Program.

Q: How is the Pre-Cert Pilot Program different from the existing regulatory model?

A: As technologies move rapidly towards an iterative development cycle, we believe a Total Product Lifecycle  approach where oversight is continuous across the life cycle will better align with how products are developed, delivered and maintained. The program envisions moving from episodic oversight to more continuous oversight, where we not only have confidence before products are marketed, we also would have confidence in the companies developing these products and have an ongoing view of how the products perform in the real-world. The program is also similar to existing regulatory model where certain lower risk products that are exempted from premarket review, and organizations are not required to submit a premarket submission for the FDA’s review but are still required to follow general controls. The program we envision differs in some parts of general controls where all organizations participating in the program, regardless of the risk of the products, would commit to sharing organizational performance and real-world performance of their products on an ongoing basis.

Q: Is the Pre-Cert Pilot Program voluntary?

A: The Software Precertification Pilot Program, is still in its build phase and not active or authorizing any products through the program. The Pre-Cert Pilot 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.

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

A: The FDA is still building the program and will provide opportunity for public input before the pilot moves to a permanent program. The pilot also is intended to inform the FDA about specific regulatory authorities needed to implement a more effective, proactive, and efficient regulatory framework for software-based medical devices.

Q: What products are in scope for the Pre-Cert Pilot Program?

A: The current focus of the Pre-Cert Pilot Program is to establish processes for SaMD technologies, which may include software functions that use artificial intelligence and machine learning algorithms.

Q: How is adaptive artificial intelligence and machine learning addressed in the Pre-Cert Pilot Program?

A: In 2019 the FDA published a discussion paper on a Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device that instantiated the Pre-Cert Pilot Program’s total product lifecycle regulatory approach.  SaMDs that use adaptive artificial intelligence and machine learning technologies differ from other SaMDs in that they have the potential to adapt and optimize device performance in real-time to continuously improve health care for patients. Because they are SaMDs, they are currently in scope for the Pre-Cert Pilot Program, which is being developed, in part, to address the unique regulatory challenges presented by artificial intelligence and machine learning technologies.

Q: How would patients benefit from this pilot?

A: The FDA anticipates many benefits for various stakeholders. We envision that this program would align the device review process with the software development process, making it more efficient and enabling faster patient access to technologies. The FDA also recognizes that increased transparency on the performance of the products will allow end users including patients to have a greater level of confidence in the products they use. The Pre-Cert Pilot Program is envisioned to provide greater transparency to all users related to the products and the organization building these products. This transparency is intended to provide additional confidence in the products at the point of use while balancing benefits and risks to patients.

Test Plan Questions

Q: Is the FDA planning to continue the 2019 test plan?

A: The FDA is continuing to build the program, including continuing the testing described in the 2019 Test Plan (or Test Plan). Although we titled the Test plan as a “2019 test plan” the Pre-Cert Pilot Program continues in its “Build and Iterate” phase to carefully evaluate the needs and expectations for the Program.

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

A: The FDA is interested in testing different elements of the Pre-Cert Pilot Program to inform the development of the Pre-Cert Pilot Program. As communicated in 2019, the FDA continues to work with software organizations as test cases on an ongoing basis and as resources permit. We encourage everyone to review our current published material and contribute to the building the program by submitting comments to the public docket. The FDA continues to review the public docket at a regular cadence, and incorporate comments, as appropriate, in building and testing the concepts of the Pre-Cert Pilot Program.

Q: Will De Novo submissions that are part of the Test Plan be used to establish special controls for the Pre-Cert Pilot Program?

A: De Novo submissions that are reviewed through current programs during the Pre-Cert Pilot Program will not lead to the establishment of new special controls for Excellence Appraisal elements or other aspects of the proposed Pre-Cert Pilot Program. The FDA first needs to determine whether the totality of evidence collected through the Pre-Cert Pilot Program framework 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 paradigm.

Q: 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?

A: As envisioned 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; requirements for notifying the FDA if certain appraisal elements are changed after the Excellence Appraisal is conducted; 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 the Pre-Cert Pilot Program 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 would serve as the predicate device for SaMD products, whether or not the developer is pursuing the Pre-Cert approach.

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

A: Companies participating in the Test Plan are helping the FDA build, iterate, and test the proposed framework in the Working Model to provide a reasonable assurance of safety and effectiveness for software products. These companies will participate in mock Excellence Appraisals to shape the process, explore real-world performance collection methods, and experiment in providing necessary information for premarket submission in an efficient way.  During these explorations the FDA does not intend to provide a stamp of precertification for companies or market authorization for products through the program.


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