Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
The AdvaMed (MedTech) Conference
San Jose, CA
September 26, 2017
(Remarks as prepared for delivery)
I want to thank you for the invitation to speak today. I appreciate the chance to share with you some of the steps that FDA is taking to advance the agency’s public health mission when it comes to our medical device program.
Before I begin, I’d just like to share a few thoughts regarding the recent hurricanes. FDA is engaged in the relief effort to all three recent disasters. We’ve been working hard in Florida and especially Texas. A lot of our efforts in those states are currently focused on helping food producers and farmers get relief from crops and production facilities that have been damaged. But as an agency, we’re especially active when it comes to the events unfolding in Puerto Rico.
As you know, FDA has a lot of agency personnel on the island. Puerto Rico has long been home to many manufacturing sites of FDA-regulated products, including devices. The island’s manufacturing base is an important part of its economic foundation. Before this devastating storm, that industrial base has been a key part of the island’s ongoing economic recovery. Helping to restore that manufacturing base is going to be a pivotal part of the island’s recovery.
At FDA, we’re doing everything we can to support our own personnel, as well as help our fellow citizens who live on the island. We’re also assisting the facilities that we oversee to get finished goods off the island and help the local manufacturing sites get back on line. We want to mitigate any potential shortages that could result from supply disruptions. Our top goal is, above all else, to support people as they deal with the aftermath of this devastating hurricane.
My senior team and I have been personally engaged in this effort. And I can tell you, from my discussions, the situation is very serious. I’m trying to plan a personal trip to the island along with colleagues at the Department of Homeland Security who’ve been leading many of the recovery efforts. They’ve been invaluable and close partners to us at FDA. I know we’ll all keep our fellow Americans in Puerto Rico in our thoughts as they begin a long and hard recovery.
I look forward to the discussion that will follow my brief remarks today. I want to share some thoughts about the FDA’s medical device program, and the new initiatives we’re working on. There’s one bottom line I want to share. It’s this: Some of the most creative, and forward-leaning advances in regulatory policy involve what we’re doing on the device side of FDA’s house. I want to share with you why I see things this way. And I also want to share some of the new steps that we’re going to be taking to further advance these policies. But let me frame these ideas with an anecdote from something that happened late last week.
I was speaking about the use of real world evidence (RWE) in support of medical product development at a conference sponsored by the National Academy of Sciences. Much of the conference discussion focused on new drug development. But it may come as no surprise to many of you that the ideas and initiatives that I was discussing in relation to new drugs, on the hope that these concepts can be put into practice, are already a key element of our approach to medical device development.
Last month, FDA issued final guidance on the use of RWE in the development of devices. Since early 2015 alone, we’ve approved or cleared more than 8 new medical devices and expanded the use of more than 6 technologies based on evidence derived from RWE. This includes drug-eluting stents, transcatheter heart valves, and technologies for spinal cord stimulation and esophageal atresia, as well as in IVDs. In these cases, we’re using robust evidence that was generated in less time and at a lower cost than in the past, in some cases saving one to two years of development time. Increasingly, medical device makers are also meeting their post-market study requirements by leveraging real world data sources.
These policy advances, first engineered in CDRH, are going viral at FDA. For example, the definitions and standards that we developed in that guidance, which was initially focused on medical devices, are being incorporated into an agency-wide policy. This new policy statement will apply to all medical products. The FDA’s consensus standard for how we describe real world evidence is going to be the mapped from the same standards we first developed for medical devices.
There are many other similar examples. The bottom line is that for a combination of reasons, we’ve been able to advance new policy and regulatory concepts in the context of medical devices that can take more time to firm up in other areas.
There are some obvious reasons for this. The first is that devices are often tools in the hands of providers, and the process for innovation when it comes to devices is more iterative. Devices are constantly being adapted and improved based on feedback from the end users and from their performance in clinical practice.
This iterative process for innovation lends itself to modern constructs for collecting and making use of data, including the use of RWE, prospective registries, or statistical frameworks that improve the reliability of practical data.
At the same time, the statute that governs medical devices is based on a more modern approach to medical product regulation. It gives FDA explicit direction to adjust the scope of its requirements based on risk. The essence of this framework gives FDA very explicit direction to require different levels of evidence as a condition of pre-market clearance or approval, whether it’s a PMA or a 510K or a de novo application that lets us establish new products as predicates.
The innovation in regulatory policy is also a function of leadership. Jeff Shuren and his team have adapted modern concepts to the regulation of medical devices. They have pioneered multi-stakeholder collaborations like the NEST program as a way to advance new models for regulation. Along the way, Jeff Shuren has built a strong leadership team at CDRH. In fact, along the way, I have poached some of Jeff’s talent to build out my own senior team. The person I asked to help lead the agency as FDA’s Chief of Staff, Lauren Silvis, was previously one of Jeff’s deputies.
Some of these modern regulatory concepts include CDRH’s focus on a benefit-risk framework that looks across the life cycle of a product. This is embodied in a series of guidance documents the center has issued. Another example is the use of patient preference information to support regulatory decisions, including product approval. Still another example is the shift of pre-market data collection to the post-market setting when it comes to medical devices. This allows patients to gain faster access to life-saving devices when it’s appropriate to accept greater uncertainty premarket and resolve those issues in the post-market setting.
CDRH is also taking a refreshed and modern approach to the center’s structure by piloting a Total Product Life Cycle Office. This concept breaks down review silos and takes a more holistic approach to product review, product and manufacturing quality, and post-market surveillance. I’ll be talking more about this concept in remarks I am giving Friday at the National Press Club. We’re doing something similar when it comes to the review of new drugs.
Traditionally, FDA approached products based on either pre- or post-market status. This siloed approach doesn’t fit the modern challenges we face. It doesn’t allow our pre-market process to be as fully informed by post-market findings, and vice versa. Our post-market teams don’t have as much access to the knowledge gained by evaluating products as part of the pre-market process. By having our teams look at products throughout the entire lifecycle, we’re enhancing their understanding of the products and their impact on patients. Deepening their understanding will, in turn, support improved application of our least burdensome approach to reviews. It’s an approach we successfully pioneered with our diagnostics office more than a decade ago.
I want to spend the balance of my time today on another one of those modern concepts that the device center has pioneered. This is the modern regulatory concept that’s embodied in the new approach we’re taking to digital health.
Today, we’re announcing an important milestone related to this program. The premise of our digital health pilot program is the creation of a premarket certification program, called Pre-Cert. Under this approach, FDA will become a certifier of firms seeking to go to market with digital health tools.
Lower risk digital health products could be marketed without FDA premarket review. Higher risk products could be marketed with a streamlined FDA premarket review. Pre-certification is used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing, and whether it has good, ongoing maintenance of its software products.
Employing a unique pre-certification program for software as a medical device could reduce the time and cost of market entry for digital health technologies.
We previously said that the digital health pilot will include nine companies. We’re announcing those companies today. We’ve had 103 applicants to date. We carefully selected the final participants in this pilot program to create a group that represents the various business models within the industry—from large tech companies and traditional medical device manufacturers to small entrepreneurs.
I am pleased to announce the participants are: Apple, Fitbit, Google, Johnson & Johnson, Phosphorus, Roche, Samsung, Tidepool, and Verily. Our team will be spending the rest of the year working closely with these companies to deepen our understanding of their methodologies and how their technologies operate. This collaboration is a key part of establishing the proper regulatory framework.
While the pilot program is filled, the opportunity to participate and engage with the FDA is still wide open. We’re going to continue to look for ways to work more efficiently with other innovators throughout the pilot. We’ll be holding informational calls that are open to the public prior to the first public meeting in January. We’ve also put out a call for interested experts to come work with the CDRH team for six months to help develop the framework as part of an Entrepreneurs-in-Residence Program, an approach the Center has already used three times in the past. The popularity of this pilot shows that the digital health industry is advancing, with many more traditional and non-traditional healthcare companies developing these applications. The pilot is an example of how the agency can collaborate effectively with developers so that entities unfamiliar with the regulatory process can efficiently advance their technologies.
This pre-cert framework is a modern approach to regulation – focusing on the product developer rather than just the product – that could have other applications across our portfolio. For example, this construct could form part of the framework for a modern legislative approach to laboratory-developed tests.
The bottom line is this: FDA’s device center has been a pioneer when it comes to a growing number of concepts for more efficient and effective regulation. I know that a lot of these ideas have depended on public and private collaboration. And so we appreciate the support of the broader medical device community in these efforts. And we look forward to working with you to build on them.
Our goal is to make sure the medical device industry is able to advance new innovation that can benefit patients. And our regulatory process must be nimble and efficient enough to enable safe, beneficial technologies to reach the market.
I want to close by thanking you again for the opportunity to join you for today’s session. We look forward to continuing to work with you to advance FDA’s mission and to achieve our vision that patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.
Thank you for having me here today.