The Food and Drug Administration is taking major steps to foster digital health innovation, including issuing guidance to provide clarity around the medical software provisions of the 21st Century Cures Act and streamlining the regulatory agency’s software review process.
Toward that end, the FDA on Thursday released a Digital Health Innovation Action Plan laying out an ambitious redesign of its policies and processes to better match the needs of the software industry while balancing the needs to protect public health and patient safety.
“We recognize that we need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions,” states the agency’s announcement. “A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.”
Bakul Patel, associate director of digital health in FDA’s Center for Devices and Radiological Health (CDRH), says the agency is taking a “very integrated, comprehensive” approach to this “fast-moving” technology. Spearheaded by the CDRH, the new plan provides details and timelines for updating current policies and issuing new guidance on several of the medical software provisions in the 21st Century Cures Act.
“While FDA had already taken a more hands-off approach to lower-risk digital health technology, including software, we will update current policies and issue new guidance to be consistent with and provide greater clarity on the 21st Century Cures Act software provision,” states the agency’s plan.
According to the plan, the agency intends to issue draft guidance on the implementation of the Cures Act for public comment by the end of 2017, explaining their effect on pre-existing FDA policy, including:
- Mobile medical applications
- Medical device data systems used for the electronic transfer, storage, display or conversion of medical device data
- Medical image storage devices used to store or retrieve medical images electronically
- Medical image communications devices used to transfer medical image data electronically between medical devices
- Low-risk general wellness products
- Laboratory workflow
In addition, the FDA intends to issue new draft guidance that delineates the clinical decision support (CDS) software that is no longer under the agency’s jurisdiction, with the goal of releasing the draft guidance for public comment during the first quarter of 2018.
Bradley Merrill Thompson, an attorney at Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says that overall the FDA’s Digital Health Innovation Action Plan is extremely well conceived.
“While the 21st Century Cures Act does much good, there are also a number of provisions that need to be interpreted and so implementing guidance will be extremely helpful,” contends Thompson. “As the agency points out, FDA also has a number of guidance documents and regulations on the books that are now overruled in effect by the legislation, and it will be very helpful to clean up all of those provisions.”
At the same time, he expresses disappointment that the FDA’s CDS software guidance will not be released until early 2018.
“FDA has been working on that guidance since at least 2011, when they announced publicly their intention to pursue it,” says Thompson. “For many years, it was a category A priority. I’m a little unsure why it will take so much further time, although I recognize that probably the agency needed to reconcile whatever existing draft they had with the new provisions of the Cures legislation. But, in my mind, this particular guidance is extraordinarily urgent and in fact overdue.”
A key component of the Digital Health Innovation Action Plan is a new Software Precertification (PreCert) Pilot Program for developers.
“This voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the software developer or digital health technology developer, rather than primarily at the product, as we currently do for traditional medical products,” states the FDA’s announcement. “This pilot will help us establish the most appropriate criteria for standing up a firm-based precertification program for these new digital health tools.”
The pilot program is set to begin Sept. 1, 2017, and the application for developers to participate will open August 1. Patel says the FDA will use the pilot participants as “use cases” to ultimately build a formal precertification program “from the ground up from the concept level to actually figuring out specific elements,” including the criteria to assess whether a company consistently and reliably engages in high-quality software design and testing as well as ongoing maintenance of its products.
“This pilot is an important first step to help us explore and evaluate elements that might be appropriate for a future precertification program, and we will use the pilot to explore whether and how precertified companies that have demonstrated a culture of quality, patient safety and organizational excellence could be able to bring certain types of digital health products to market without FDA premarket review or after a more streamlined FDA premarket review,” according to the agency.
Health IT Now, a coalition of patient groups, provider organizations, employers and payers, applauded the announced pilot program.
“By allowing proven, trusted developers to use a more streamlined submission process, our nation's digital health device and software manufacturers can spend more time engineering new product and less time worrying about regulatory hurdles,” said HITN Executive Director Joel White.
“The FDA’s pre-certification program will test whether low-risk software should get expedited review. If done well, this program has the potential to provide clarity and a fast track process to new consumer and patient applications,” White added. “This should encourage more product development and more investment in patient tools that will improve health. We want to reward excellence and ease approval burdens on developers.”
On August 1, the FDA will host a webinar for industry to provide additional information about the precertification pilot program and to answer questions from developers. No registration is required.
Thompson, who calls the pilot a brilliant idea, is encouraged by the fact that the FDA is suggesting that perhaps the final precertification program could make it unnecessary to file a 510(k) premarket submission for certain presumably low-risk digital health products. Further, he believes that many firms will sign up for one of the nine slots to participate in the pilot.
“In the Federal Register notice, the agency provides the criteria for qualifying, and they’re not too stringent,” Thompson concludes. “I think it will be more a matter of FDA choosing a wide variety of firms, as they suggested they will. And, that is in fact extremely important because established firms will view these issues differently than new entrants, and large companies will view it differently than small companies. And, we will need a program that caters to all of those. We cannot, for example, lose the strength of having small firms participating in digital health innovation.”
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