Over and above clearing a number of devices, the FDA had a busy year in 2016, passing a number of draft and final guidances related to digital health, having some notable conversations with vendors, and even turning down some devices whose FDA clearance was expected this year. We've rounded up the year's 510(k)'s in a separate article, but here's a rundown on some of the other actions the regulatory body took, as well as a brief look ahead at what 2017 might have in store for the FDA.
New guidances and publications
The year for FDA guidance news started in June when the agency came out with a draft guidance designed to help medical device makers better understand how the agency thinks about patient access. While this guidance document encourages device makers to share data with patients, it also suggests these companies take into consideration the best way to share this information "to ensure it is useable by patients and to avoid the disclosure of confusing or unclear information that could be misinterpreted." As we reported at the time, the guidance ties into one of the hot button issues in patient advocacy -- the rights of patients to access data from their own medical devices. Industry groups responded to the guidance with a request for more clarity in the final document.
In the last week of July and the first week of August, the agency dropped three more guidances, two draft and one final, with ramifications for digital health. The final guidance, "General Wellness: Policy for Low Risk Devices", aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. The document outlines two different categories for general wellness devices that fall outside of FDA regulation. Of the two draft guidances, one dealt with use of real-world evidence to support decision-making and one would provide additional clarity for software manufacturers specifically about when a software modification requires a new 510(k) clearance.
In October, the FDA added another draft guidance into the federal registry, this one not penned by them but by the International Medical Device Regulators Forum, of which FDA is a member. The guidance seeks to articulate what's new and different about Software as a Medical Device (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. MobiHealthNews uncovered in a recent investigative report that Apple served as a secret advisor on that guidance as well.
Finally, just last week the FDA released a final guidance outlining how manufacturers should maintain security of internet-connected devices such as pacemakers and insulin pumps. The FDA recommends that manufacturers continually monitor cybersecurity vulnerabilities, create a program to mitigate these risks, and work with researchers to address issues early on before an exploit can occur.
In one more publication that isn't a guidance, the FDA proposed plans to conduct studies on whether they should change how drug side effects are required to be published on social media. The agency plans to conduct four studies, two on Twitter and two on Google ads, with a total of 6,502 participants. The studies will test consumer behavior around an ad for a fictional weight loss drug and a fictional treatment for migraines.
Devices not yet cleared
We tracked several FDA processes this year that have yet to lead to a clearance, demonstrating that the agency is far from a rubber stamp, especially when it comes to new and innovative devices.
In April, the FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health's ingestible sensor. The drug, a collaboration between Proteus and Otsuka Pharmaceuticals, combines the Proteus system with the antipsychotic pharmaceutical Abilify. Proteus and Otsuka submitted the system as a new drug application (NDA) in September 2015. Because both halves of the system are already cleared or approved by the FDA, the companies expected a swift approval. Instead, they were issued a Complete Response Letter (CRL), a non-public document issued by the FDA that lays out the additional steps a non-approved drug must take to secure approval.
The Scanadu Scout, a home health sensor device that was sold pre-approval as an investigational device on Indiegogo, hasn't received FDA clearance yet either, a situation which required Scanadu to effectively brick the devices that early backers had paid upwards of $200 for. That prompted some backlash from Scanadu customers, but the company maintains that it is still on the path to FDA clearance, and the data collected in that study will help them get there.
Senseonics, the Germantown, Maryland-based company which went public in January and is working on a longterm implantable continuous glucose monitor, submitted for premarket approval in November. The company, which has a CE Mark and is selling its product in many countries in Europe, is awaiting FDA clearance to break into the US market.
Of course, MobiHealthNews learned this year from a FOIA request that Apple has been in extensive conversations with the FDA about at least three devices that would require clearance: two separate but related cardiac devices and a diagnostic app for Parkinson's disease.
Looking ahead -- Trump and 21st Century Cures
Like most things that involve the federal government, the future of the FDA is a little unclear right now as we await the inauguration of Donald Trump as president. Most in the industry agree that Trump is likely to relax rather than increase regulation, and his tentative pick of venture capitalist and libertarian Jim O’Neill as commissioner seems to support this.
"From everything I've heard, Trump is very supportive of technology development, and very concerned about regulatory red tape. So I think we can feel confident that Trump will certainly not increase the regulation of digital health," Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA, told MobiHealthNews in an email back in November.
Additionally, the 21st Century Cures Act that just passed will have some impact on the FDA. For digital health companies building software for clinical decision support, the bill brings clarity over how the FDA would seek to regulate them. As health software companies are working on technology to help doctors do a more thorough job in both diagnosis and treatment decision-making (through apps, telemedicine and digital references), there is a real need for clinical guidelines, and Cures provides some clarity on those.
What the bill fails to specifically address is deadlines for implementation -- particularly with regards to the role of the FDA in establishing a “breakthrough device pathway” for the approval of medical devices. The bill requires the agency to build upon the existing priority review device program and improve the medical device classification review process, as well as identify five types of low-risk medical software that will not be regulated as medical devices.
Thompson pointed out in a recent email to MobiHealthNews that the agency's proposed list of guidances to publish in 2017 notably does not include draft guidance on clinical decision support software, which has appeared on the list the last two years.
"As I understand it, FDA removed it from the list because they plan to reevaluate the need for CDS guidance in connection with implementing the 21st Century Cures legislation," Thompson wrote. "That legislation, in section 3060, adds the criterion that to be FDA regulated, CDS software must not be transparent. In this context, transparent means that the doctor user cannot see through the software to the underlying patient data and the clinical logic applied by the software, such that the physician is not required to rely on the software. ... My hope is that in connection with the legislation, FDA proceeds with the guidance. Indeed, the guidance is more important now than ever before."
Thompson said the guidance is still needed for several reasons, including to address clinical decision support software that is not transparent and to provide guidance on how FDA will enforce transparency standards.