Agency looking for appropriateness of definition, approach

WASHINGTON D.C. — The deadline – October 19 – for public comment on the Food and Drug Administration’s draft guidelines for the regulation of medical apps is fast approaching.

There’s no shortage of feedback, and so far comments have been “very favorable” in terms of “supporting this first step,” according to Bakul Patel, policy advisor for the FDA’s Center for Devices and Radiological Health.

There is “a bit of confusion,” especially for those who aren’t used to FDA regulations and language, of what falls within and outside the scope of the language, Patel said. “There is a need for clarity,” he added, which the FDA’s public workshop, held on September 12-13 in its Silver Spring, Md., center, was designed to help bring.

The agency is still soliciting feedback on how appropriately and clearly the agency has scoped its approach and definition. The guidelines were written for a broad population, and the agency was striving to strike a balance between its main focus of patient safety and the benefits and risks of mobile medical apps, Patel said. “The answers will help us either add more details to the guidance or provide a different way of explaining it,” he said. “We want to propose the right level of oversight.”

The FDA is tasked with a significant challenge, said Bradley Merrill Thompson, partner at Epstein Becker & Green, PC and general counsel for the mHealth Regulatory Coalition. “It’s a fast-moving area with complicated technologies and some fairly novel issues created by this new technology,” he said. “They have to write something that is clear to everyone.”

The mHealth Regulatory Coalition, which comprises companies involved with m-health, was formed in 2010 to specifically work with the FDA to write a guidance document that addresses what gets regulated and what doesn’t. Several of its members spoke at the FDA workshop and submitted two documents. The comment letter points out areas of the draft guidelines where the intent is unclear, and the second document is a proposal that provides actual language for specific changes to the guidelines.

The FDA has been trying to figure out how to regulate software, particularly software related to the Internet, for the last two decades, Thompson said. “They haven’t figured it out. As a result, they’ve stayed on the sidelines and that’s been unfortunate,” he said. “We all need guidance. We all need to know what the rules are. There are rules; they are just not articulated yet.”

Given that the mobile medical app market is evolving rapidly, Thompson suggested that as the FDA frames its rules it needs to stay focused on a higher level of generalization than people want, areas of risk and where basic scientific principles can be applied in order for the guidelines to be useful over the long haul. “We’re not asking FDA to be prescriptive – we’re not asking them to say a mobile app has to do exactly this and be exactly this dimension and so forth,” he said. “We’re looking for them to set forth the framework under which these things are being reviewed. Stay focused on risk, stay focused on principles of framework, and let us innovate within that framework. That’s really what a regulator needs to do.”

The Continua Health Alliance, a nonprofit industry organization with more than 240 members comprising healthcare and technology companies dedicated to improving the quality of personal healthcare, is also actively working with the FDA. “As a trade association, we represent the voices of many and give an industry perspective,” said Executive Director Chuck Parker.

The introduction of the guidelines “helps us as an industry that has been operating in a gray area,” he said. Specifically, the alliance is providing feedback around determining what constitutes clinical decision support with regard to medical apps. In addition, also recognizing the risk of outdated regulations in an innovative market, Parker said, “We’re trying to help them understand what we see in the next three to five years, where the market is going.”

Rene Quashie, government relations director/regulatory attorney for Drinker, Biddle & Reath’s Government and Regulatory Affairs Practice Group and regulatory attorney for the Center for Telehealth and eHealth Law, agreed that guidelines remove uncertainties for manufacturers and others as to whether their product is under FDA jurisdiction at all and what steps are required of them if they are covered. “Manufacturers now have guideposts to help them navigate through their development process,” he said. Still, many manufacturers are scrutinizing the definition to ensure that it accurately captures and scopes what the technologies actually do, he said.

Quashie doesn’t see the guidance itself as stifling innovation, although it remains to be seen how much further the FDA is going to go in terms of not only guidance but actual regulations. One clue, he said, may be the final rule that the FDA issued regarding medical device data systems (MDDS), which receive data from medical devices, convert data from one format to another and store and make data available to other systems but do not have any real-time active or online patient monitoring functions.

The final rule, which went into effect this past April, reclassified MDDS from Class 3 to Class 1, which subjects them to general regulatory control and exempts them from premarket notification requirements. “This is a signal that the agency is getting a pretty good handle on its ability to protect patient interest and the public health and not stifle innovation,” Quashie said. “This is an example of the agency doing a very good job of recognizing that tension and coming out on the right side of things.”

While the guidelines will “put a damper on many of the outlandish claims that some apps make in relation to healthcare,” actions such as FDA recalls will decide the future of medical apps and mobile phone use, said Zachary Bujnoch, senior industry analyst for telehealth at Frost & Sullivan. “One very real possibility that these guidelines further enable is a major FDA-mandated recall of an app on the iTunes store,” he said. “These types of events will have to be dramatic in mobile health, and these guidelines are another step further enabling them.”

Identifying a subset of potential devices and software that might fall under FDA jurisdiction was an easy exercise, given that many of the devices in the subset are closest to existing regulated medical devices, Bujnoch pointed out. Still, there are many questions surrounding such apps as those for diabetes management.

“The FDA seems to be trying its best to link such questions to existing regulation, but companies still are struggling to figure out definitive answers,” he said.

Bujnoch echoed what everyone in the mHealth industry is saying: “With FDA regulation of apps and mobile device an eventual necessity, this is simply a first big step into a very long-term process of defining what and how the FDA is going to regulate these new types of devices.”

Patel declined to set a timeline for when the final rule will be released, given the amount and complexity of feedback the agency has already received. The comments will determine how the agency addresses the issue.

“Our intention is not to have any unintended consequences of market changes, but to really focus on safety for patients,” he stressed. “When clinicians, patients and users use this for making real clinical decisions, we need to have the same assurances as we do for medical devices.”