Health Subcommittee Reviews FDA Final Guidance on Mobile Medical Devices

November 19, 2013

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), held a hearing today on “Examining Federal Regulation of Mobile Medical Apps and Other Health Software.” Today’s hearing reviewed a final guidance by the Food and Drug Administration to regulate mobile medical applications and certain health-related software. The hearing followed up on the committee's three-day hearing series last spring in which the committee worked to provide much-needed certainty for patients, providers, and innovators. FDA has already pledged not to regulate and tax consumers’ smartphones and tablets.

“In September of this year, the Food and Drug Administration put forward a proposal, in the form of final guidance, indicating that software was a medical device for the purposes of regulation—except that software is not a medical device,” said Pitts. “To regulate it as such, the FDA has said it will use discretion to decide which software to regulate. Except that no matter what Dr. Shuren tells this committee here today, there is no guarantee that his successor won’t go back on this guidance tomorrow. While guidance is a valuable tool for the FDA, there is a significant limitation: certainty. What stands today could change tomorrow.”

In September 2013, FDA issued final guidance indicating its intent to regulate apps as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. While this move would allow the agency to regulate all mobile medical apps, FDA also announced its intention to use enforcement discretion to regulate only a subset of all mobile medical apps, including those that are used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device.

Today’s hearing also examined full committee Vice Chairman Marsha Blackburn’s (R-TN) bipartisan legislation, H.R. 3303, the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013 that seeks to create regulatory certainty by giving FDA a new tool to regulate some forms of emerging technologies without regulating them as medical devices. 

Michael Marchklik, Vice President of Quality Assurance and Regulatory Affairs with McKesson Technology Solutions noted that the SOFTWARE Act would establish three distinct categories of health IT including: medical software, clinical software, and health software. “This legislation calls for the FDA to continue to regulate the highest risk category of ‘medical software’ and charges Congress and the administration with collaborating in the development of a new risk-based regulatory framework for ‘clinical’ and ‘health’ software,” said Marchklik. “These classifications recognize that the risk associated with health IT, and hence the intensity of regulatory oversight, should be based upon the severity of potential harm to the patient as well as the opportunity for a clinician to intervene between the technology and the patient.” Zachary J. Lemnios, Vice President of Research Strategy for IBM added, “patient safety can actually be improved when regulatory structures promote innovation and shorten time-to-market.”

Jim Bialick, Co-Founder and Executive Director for the Newborn Coalition discussed the special needs many newborn children face and how apps play a crucial role in their early health. In the existing market, high costs are typically associated with many newborn-specific products and as a result there are few products on the market for newborn patients. Mobile medical applications offer enormous benefit for these patients in particular, Bialick noted, “mobile apps and the smartphones and tablets are easily accessible, intuitive, and commonly used by parents. These technologies will continue to play a central role in healthcare but their impact will be stunted unless there is a concerted effort to allow these technologies a way to access and creatively use clinical data to better inform the decision making by both providers and parents in the ongoing care of a newborn.”

Committee Chairman Fred Upton (R-MI) explained, “The FDA’s decision to step in and regulate some of these technologies – by their own admission not all but some – is something I think most people view positively. The issue for this committee is how the FDA seeks to regulate in this space and what that means to patients and innovators both now and in the future.”

 

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