At a hearing last week before the House Energy and Commerce Committee, representatives from across the health IT industry weighed in on Food and Drug Administration oversight of health IT.
In September, the FDA released final guidance on medical device oversight. According to the issued guidance, apps that will be monitored by the FDA meet the definition of "medical device" as set forth by the Federal Food, Drug and Cosmetic Act; technologies that are intended to either transform the mobile device into a medical device or be used as an accessory to a medical device.
In response to the issued guidance, Reps. Marsha Blackburn (R-Tenn.), Gene Green (D-Texas), Phil Gingrey (R-Ga.), Diana DeGette (D-Colo.), Greg Walden (R-Ore.) and G. K. Butterfield (D-N.C.) introduced the Sensible Oversight for Technology Which Advances Regulatory Efficiency Act, which aims to both clarify the FDA oversight framework and strike a balance between patient safety and innovation.
Health Subcommittee Chairman Joe Pitts (R-Penn.), opened the hearing by declaring the FDA's definition of medical device to be too ambiguous, and praising the SOFTWARE Act. The first witness, Jeffrey Shuren, MD, JD, the director of the FDA's Center for Devices and Radiological Health, said the guidance, based largely on health IT stakeholder input, did provide clarity, and he defended a clause giving the FDA some discretion to determine whether new technology should be considered a medical device. Dr. Shuren also urged lawmakers to wait and evaluate industry response before passing the SOFTWARE Act or similar legislation.
Michael Marchlik, vice president of quality assurance and regulatory affairs at MeKesson Technology Solutions, voiced his support for the SOFTWARE Act and for clarifying FDA oversight of medical technology. "The definition of medical device in the Act is so broad that it can be, and has been, interpreted to include all health IT," he said. "In my role at McKesson, I recognize the important distinction between the regulation of traditional medical devices and the regulation of rapidly evolving technology. Applying a four-decade old approach to mobile and cloud-based technologies that did not exist even four years ago is ill advised."
However, J. Leonard Luchtenfeld, MD, deputy CMO at the American Cancer Society, urged the committee to reconsider the SOFTWARE Act, citing the need for a more adaptable framework. "Some of the technology in use today was almost unheard of five years ago, so any new oversight structure should not be so rigid that it cannot quickly adapt to new realities," he said. Instead of an overarching framework, he suggested narrower policy changes aimed at specific subsets of medical software.
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