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How Best to Work with FDA to Navigate mHealth Regulation

By Kyle Murphy, PhD

- Despite providing leeway for mobile health technology developers, the Food and Drug Administration (FDA) still has a major role to play in setting boundaries for future mHealth innovation.

Marc Scheineson heads up Alston & Bird’s Health Care Group, include mHealth regulation

"FDA is trying to balance two things," Marc Scheineson, Esq., partner in Alston & Bird’s Health Care Group and head of the firm's Food and Drug Law Practice, tells mHealthIntelligence.com.

"They are trying in a rapidly developing marketplace not to discourage innovation," he continues, "and that's coming more from the White House and HHS/ONC and on the other side trying to draw some bright lines to the extent that it can generalize to give some certainty to technology companies about which side of the line they're on and what the cost and regulatory pathways would be."

As a former Associate Commissioner of the federal agency, Scheineson can understand where FDA is coming from while at the same time remaining skeptical as to whether it will continue down the proposed path for mHealth regulation.

"It remains to be seen whether they stay on their side of the line," he maintains. "The agency is a conservative, an aggressive, and an incremental regulator. It likes to see technology and have a piece of the development of these products, especially if they are going to be patient-specific and diagnostic in setting."

Regulatory oversight of mHealth, however, isn't limited to FDA. The Federal Trade Commission also has a stake that mHealth developers need to be mindful of, especially where 510(k) clearances and premarket approvals (PMAs) are concerned.

"The FTC gets a piece of this on the advertising side because they regulate the ads for non-restricted medical devices, the 510(k) devices that come in as substantial equivalents and not needing human clinical trials as a PMA would need," Scheineson adds.

Staying on the right side of the line (and FDA)

Mobile health devices and applications are already in the hands of consumers but much less so in the hands of providers. According to a 2014 Deloitte survey of physicians in the United States, slightly less than one quarter reported actively using mHealth technologies despite nine out of ten reporting interest in their clinical value.

So where is the disconnect? It could be the result of mHealth developers not knowing how to work with FDA, says Scheineson.

"It's very easy for FDA to get in the way," he maintains. "They are sort of an 800-pound gorilla with a lot of weight to throw around, but they should be viewed constructively as a development partner. To the extent that companies want to do it right, FDA reviewers are the experts on clinical studies and their structure. The agency is pretty open and have reached out."

The success of certain developers proves the value of taking a proactive approach to engaging the federal agency.

"Smart companies that are pretty sophisticated and really want the technology to work will come forward in that way. If you're looking long term, which is hard to do in the IT business if you don't have the right idea, you can design a paradigm that will be verifiable," Scheineson adds.

Considering the costs associated with the FDA regulatory process — ranging from $5k to $10k on the low end — mHealth developers may have to modify their market approach to sustain their operations in the long run.

"What a lot of companies try to do is get to the market as quickly as they can and maybe have less functionality in their designs and products," Scheineson continues, "and once they have revenue coming in they use that revenue to do some clinical research or evaluate a product in a way that will allow them to make more direct diagnostic or stronger health claims."

That is not to say that working in an upfront manmer with federal regulators isn't fraught with its own setbacks.  

"If you approach the FDA and seek their advice, they can be constructive players," Scheineson explains. "The two rules of thumb are: (1) don't ask open-ended questions, have a regulatory framework in mind that is justified and get them to endorse that if you can, and (2) if you ask them a question, you haveto listen to their answer."

The mHealth regulatory environment is still developing but FDA is already sending warning signs to companies deviating from its guidance, but its evolving nature gives mHealth developers the opportunity to have input into how it ultimately shapes up.

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