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On May 10, 2018, the FDA held the first "FDA User Session," delivered as a public webinar, as a follow-up on the Digital Health Software Precertification (Pre-Cert) Pilot Program. I attended because I believe how the FDA is, in coordination with industry, shifting its regulatory approach, will have a large impact on the innovation and development of new medical and consumer health products. I expect this, in turn, to have a profound impact on health and well-being, early detection of medical problems, and on how the consumer navigates the changing world of health and well-being.

The moderator, Irene Aihie, introduced the session with "The FDA recognizes that we need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, its unique user interface and the industry's compressed commercial cycle of new product introductions." The key goal of the meeting was to review and to seek feedback concerning the newly-released model of this program. The Pre-Cert Pilot Program is one of the elements designed to fulfill on their larger intention of working in partnership with the public in designing their new, streamlined regulatory processes.

The FDA has been tasked with streamlining its regulatory processes to stimulate innovation, and has started redesigning its processes to fulfill on the goals of the 21st Century Cures Act. The Pre-Cert program and the accompanying models is its initial test case for this.  They have started with a clearly-delineated area, SaMD (Software as a Medical Device) as the first place to gain experience. By restricting the initial pilot to the limited area of software-only, the complications relating to multi-function systems don't come into play. This leaves those more complicated arenas to be sorted out in the future.

The idea of the Pre-Cert Program is to use knowledge about an organization to permit certification that it is equipped to monitor its internal processes and resulting quality. Certified organizations would then have access to a streamlined regulatory process. During and after market release, real-world data will be collected, feeding into the market review and into the continual monitoring process of the organization. This flow is captured in the following slide of the process flow. Because the program “relies on a demonstrated Culture of Quality and Organization Excellence,” this permits an organization to take over some of the regulatory burden from the FDA.

Pre-Cert Program process flow diagram

One could argue that much of the value, and the synergy, of this model comes from the feedback loop, shown in the figure, the Pre-Cert Program process flow diagram, from U.S. Food & Drug Administration, "Developing Software Precertification Program: A Working Model [v0.2 - June 2018]". Starting in the upper left of the Pre-Cert Program process flow diagram, KPIs (Key Performance Indicators) are collected by the organization, and serve as indicators of the organizational excellence and process controls, which enable determination of the Pre-Cert level, as well as ongoing verification of this level. This level then enables a streamlined review process specific to that organization. During and after the review process real-world data are collected. These data enable discovery of device and process characteristics, empower early detection of any potential problems, and permit analysis of the organization operating characteristics, which are then captured in the KPIs.

The potential available from collecting the real-world data is to 1. discover and react to problems much quicker with such an approach, and 2. create continuous process improvement within the organization. Both of these would lead to a safer environment for the patient.


Bakul reported we are "1/3 of the way into the program. We are "trying to launch a pre-cert 1.0 by the end of this year... one of the callers talked about testing the program and testing their products and trying it out and working out some of the issues. So that’s what we plan on doing in 2019. And we’ll have another iteration that will go out at the end of 2019."

The FDA has a team working on this, and they are making this a collaborative effort, starting with the selection of the nine pilot program participants, through the Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018 that I reported on earlier: Public Workshop; through this user session and the following user sessions, and through the opportunities for the public to provide feedback on the developing models and guidance, such as responding to the Challenge Questions.

The focus is on SaMD (Software as a Medical Device) as the first place to gain experience. They intend to apply the learning to on SiMD (Software in a Medical Device) in the future, though no timeline has been laid out; this represents a more complicated case, as it involved the Multi-functionality guidance described above.


  • June 19, 2018               Publish Precertification Program Working Model Update
  • May 10, 2018                Digital Health Software Precertification User Session
  • April 26, 2018               Publish Precertification Program Roadmap, Working Model, and Challenge Questions
  • January 30-31, 2018     Public Workshop: Developing the Software Precertification Program
  • May 10, 2018               FDA User Session

In just 6 months the FDA has collaborated with the Pilot Program members (Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily) and the public at large to create and iterate on the model. A lot will still need to be formulated during the last half of the year to release Pre-Cert 1.0 by the end of 2018.

My takeaways

The FDA has charted a course involving the public in creating the new processes designed to streamline regulation while maintaining safety. By its nature it is an iterative learning process. The good news is that the outcome isn’t known; the downside is the uncertainty; the upside is the ability to make significant changes to the old processes which were designed for a different era.

Speeding up processes while maintaining safety is highly challenging. It will require excellent thinking, both on the part of the FDA, and in the feedback coming from the public. The nine pilot program participants have a key role to play – they were selected to cover a wide swath of types of organizations; their partnership in thinking through how such a program would work well in their organization will guide how future iterations of the program will be designed.

The model discussed in the User Session focuses on feedback loops. How these loops are designed and integrated is where the synergistic value of this program can arise. As organizations create good methods for monitoring and reporting their internal processes, and the FDA learns how to inspect and interpret these, this will enable streamlining the evaluation process. It is fundamentally a trust-based process: what does an organization need to do to be able to trust itself? And then what must it do to win the FDA's trust? It is this trust that allows process streamlining without sacrificing safety, and will eventually enable the FDA to focus its limited resources on the highest risk areas.

Current product development technologies, and particularly for software development, incorporate fast turn-around. The traditional long-time-line FDA processes haven't been in alignment with this. Faster product development cycles can't be achieved unless the organization doing the development plays a larger role in its own regulation. Since no one knows how to do this, such processes are now being created. Now is the time to provide feedback to the FDA about how best to do this. Much of the burden falls on the organizations, not on the FDA, for designing good approaches to achieve this.

If the regulatory process impacts you, now is the time to get your voice heard; perhaps there will never be another time where the FDA is in such a receptive position, and so interested in feedback from the greater public. There are several channels for communication, such as in participating in future User Sessions, or answering the FDA's Request for Feedback for each aspect of this program, as documents become available for commenting. The "devil is in the detail," and thus detailed feedback can have a large impact on the progression of the development of the new regulatory approaches.

Previously, intellectual property was a key currency engaged in by companies. I see this as shifting towards a new currency: who owns the data? And of what quality is it? The real-world data collected by the organizations will be pivotal to the regulatory process, to patient safety, to development of the organization's internal quality processes, and towards development and refinement of future devices. As it amasses, it will become a treasure trove. And I expect the FDA will reward organizations who are willing to share their data, which benefits such as reduction of regulatory burden. Because of the large value of the data, some organizations will choose to not share their data publicly - but rather, only the KPIs extracted from the data.

What are the implications for your organization?

For your business, a key potential upside would be reduction in time to market, reduction in the uncertainties of the regulatory process, and the ability to release product updates on the timescale of sprints, rather the timescale of previous FDA processing (typically in units of 6 months). I think in the long term, these benefits will be realized, but shorter term, as the FDA and industry are sorting out how all this will work, I don't expect to see a reduction in the uncertainties, and it's not yet clear what the extent of the streamlining will be. In this initial period when the processes are getting sorted out, both your organization and the FDA will have to dance with the unknown, as the systems are being created.

The potential upside is being able to release a product, or multiple products more efficiently. For example, one of the companies in the Pilot program, Pear Therapeutics, has at least 10 products in its "eFormulations™" development pipeline. The ability to get more of these products released in the market sooner will make a huge difference financially. 

One can expect that achieving the status of pre-certified will serve as a poker chip, which will unlock funding doors. Investors will be more interested in a company where it is clear there is a shorter regulatory path.

An implication of the pre-certification model is that there is a greater burden of proof on an organization. There are pros and cons with this. The pro is greater degrees of freedom, the opportunity for an organization to better determine its future. The downside is the burden of creating systems to verify and validate that your organization's processes are appropriate and sufficient, and that the KPIs you choose will both satisfy the FDA as well as be useful for you as an organization to monitor and validate your quality. Thus it is appropriate for the different constituents of your organization to put considerable thought and have frank internal discussions of what KPIs will best drive towards success for each of these.

Will the Pre-Cert program help you? For now, the first question is: is it a software-only product? Since the pre-certification program so far is only focusing on SaMD, it can only impact the software-only products. The FDA said it intends to focus later on multi-functionality products, but has given no timeline on well it will shift its focus. If you will be releasing both software-only and multi-functionality products, it could at least help with the software-only products.

The next question is: how well positioned you are to demonstrate your quality systems? Since the program relies on your ability to convince the FDA (and yourself!) that you will be a good bet for releasing a quality product, you will need to evaluate how big a burden this will place on you. Do you already have significant products on the market, where you have already demonstrated your abilities with monitoring quality, and with the implementation of quality systems commensurate with the risk? If you have no SaMD products currently on the market, you will have a greater burden of proof to demonstrate the FDA should trust you to monitor your own quality and to release safe products. In this case, you will need to assess the balance between the burden of creating that demonstration of evidence, against how many products you plan to release, and with what timeline. If you only plan on releasing a single product in the near future, it may not warrant the effort require to create the necessary internal systems and proving your systems to the FDA. If you already have numerous released SaMD products, or if you have a pipeline where you are counting on releasing multiple products, it will probably justify any up-front effort. Another factor to consider is the advantage of the pre-certification status, per se - having that poker chip in your hands will open certain doors. There are also the non-tangibles: the closer relationship with the FDA that comes with being pre-certified could be a big plus.

If you are a large business, you may have multiple organizations within your business, each of which might separately need to become pre-certified. It is a function of quality systems deployed - if you have one company-wide quality system it is more likely you could be pre-certified across the entire company, and particularly if products from the different organizations have similar risk profiles.

If your organization is in the process of releasing SaMD products, it may be worthwhile to

  • Understand and provide feedback to the FDA on the new regulatory processes
  • Become one of the second phase of pilot companies. Becker's Hospital Review reports that "At the AAMI conference, Mr. Patel said the agency will select additional companies to participate in the initial pilot program through the end of 2018."

We're working on multiple consumer health, medical device, and connected system developments, from a connected inhaler for improved adherence, the NEXThaler®, to the KiCoPen connected insulin device, to a wearable system for monitoring stress.

We're actively following the FDA progress with SaMD and the Pre-Cert program to enable us to best help our clients navigate the changing landscape, capitalize on new opportunities arising from this, and get innovative new ideas rapidly to market. Later this summer a whitepaper will be released that explores the implications of these changes.

David Ritscher
Connected System Architect
With a focus on connected devices, consumer products, wearables, and implantable medical  devices; design of sensor systems, algorithms, DSP, machine learning; experienced in bringing new concepts from ideation to research and development through successful product launch