FDA OK Too Slow for Medical Apps, Smartphones, Samsung Official Says
The length of time it takes the Food and Drug Administration to sign off on mobile devices through its 510(k) approval process can be a major impediment for expanding “mHealth” (mobile health), a key priority of the wireless industry, Zachary Rothstein, senior manager-regulatory affairs at Samsung Electronics America, told an FCBA discussion on broadband and healthcare Tuesday. A standing-room-only crowd packed a conference room at CTIA for the discussion.
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The average approval time for medical apps submitted to the FDA is three to six months, based on a recent survey, Rothstein said. “Historically speaking, that’s not a terrible approval time for FDA,” he said. But for smartphones and apps, three to six months “could be a product’s entire life cycle,” he said. Getting products to market quicker is critical for companies like Samsung, he said.
Another big question is what changes to a device or app trigger a requirement for the filing of a new 510(k) application, Rothstein said. The FDA guidance isn’t clear, he said. For a medical device company changing a device, filing a new form may not be a big deal, he said. But for an app, “the question is to what extent does a change to software really require a new 510(k),” he said. “We might change the user interface a bit. ... We might update a bug.” Uncertainty has kept some larger players from wanting to get involved with medical apps, he added. Big companies “like certainty,” he said. “Certainty means going to market.”
The U.S. healthcare system sees a 11-1 return on investment for the dollars in spends on mobile health, yet less than 1.1 percent of patients with chronic diseases have access to an mHealth system, said Tom Reid, coordinator of the Southern Ohio Health Network (http://bit.ly/1r6FOt6), who also spoke Tuesday.
"Why are we so slow in using what is clearly a very powerful tool to improve care?” Reid asked. Reid blames in part the disruption in the healthcare industry, which he said views its future as “half empty.” Healthcare providers are reimbursed based on “how sick” their patients are, not “how healthy” he said. Change comes to healthcare very slowly, he added.
Reid also said mHealth initiatives have a very real effect on broadband deployment. In 2009, Reid said his group looked at broadband deployment in rural Ohio and found that almost 60 percent of the state had no access at all. Using federal grants from the FCC and the NTIA’s Broadband Technology Opportunities Program, the network spent some $130 million on broadband in the southern part of the state, he said. Carriers followed. “There’s the money we spend and then there’s the money we caused to be spent,” Reid said. “Suddenly the incumbents rushed in” and spent five to 10 times as much as the group had spent on expanding their networks there, he said. “Suddenly there was a lot of fiber available where before there was none,” he said.
Matt Quinn, director-health care initiatives at the FCC, said the agency works closely with other agencies and industry on mHealth. “FCC is not a healthcare agency,” he said. “We have a limited, but very important role, in catalyzing new care models in health technology innovation.”
The FCC is seeing growing interest in its Healthcare Connect Fund, which provides support for broadband, Quinn said. As of the end of May, the agency had received 76 new applications for funding just in 2014, from different consortia, he said. That compares with just 50 applications during a seven-year healthcare pilot program.
Meanwhile, CTIA filed comments Monday (http://bit.ly/1stuKX4) on the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework. CTIA recommended the government develop a “more nuanced approach to determining which health IT products are unregulated, regulated by FDA or subject to the regulatory framework proposed for health management health IT.” CTIA said the government should focus on “the risk profile inherent” in a specific product, “rather than a generic category of administrative software, health management health IT, or medical device.”
The Telecommunications Industry Association also filed comments, recommending against a proposal that all health technologies be divided into three broad categories (http://bit.ly/1r6EC96). “Rather, we urge for a more flexible, granular approach to products and devices while also reflecting the overall service being delivered to the patient on the network or system level,” TIA said.