Press Release

Blackburn measure implemented to put digital health care in consumers’ hands

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WASHINGTON, July 27, 2017 | comments

WASHINGTON – Rep. Marsha Blackburn (R-Tenn.), a member of the House Energy & Commerce Subcommittee on Health, on Thursday praised the FDA’s launch of its Pre-Cert for Software Pilot Program, which implements legislation she authored that became law as part of the 21st Century Cures Act. The FDA program changes the regulatory process for certain medical devices, allowing firms making digital health products such as apps, to get their technology into the hands of patients and consumers so they can reap the benefits of the latest innovations and take an active role in their own health care.

“Americans today lean on apps for everything from scheduling to grocery shopping to entertainment,” Blackburn said. “Why shouldn’t they be able to use those technologies to monitor and maintain their health?”

Certain medical health apps are currently regulated as medical devices and subjected to traditional medical device regulations. But it doesn’t stop there. Each and every upgrade to those apps is required to go through the same regulatory process. All of this means that apps that could bring significant health benefits, lower costs, greater access, remain tied up in bureaucracy for far too long – often outliving their usefulness before ever coming to market.

“With the speed at which today’s technology changes and updates, the FDA’s traditional, heavy-handed regulatory framework simply isn’t feasible for things such as apps, which can provide a significant benefit to consumers and patients so long as they have access to them before its obsolete,” Blackburn continued. “This was the focus of my SOFTWARE Act. By employing a light-touch regulatory approach and establishing a thorough pre-certification program, developers will be able to efficiently deliver the latest technology to those who stand to benefit most from it.”

The Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act, originally introduced by Blackburn in 2013, was included in the 21st Century Cures Act and signed into law in late 2016.

Blackburn highlighted the significance of this announcement for jobs and the extensive health technology and IT sectors in Tennessee. Her Nashville-area district is home to numerous health care innovators and companies, and has been dubbed the “Nation’s Health Care Industry Capital.” Her district also neighbors Memphis, where one in every four jobs are linked to the medical device industry.

The FDA’s pilot program aims to evaluate a new approach toward software products, including a precertification program for the assessment of companies that perform high-quality software design and testing. This voluntary pilot program is part of FDA’s ongoing efforts to develop pragmatic approaches to balance benefits and risks of digital health products. FDA intends to develop a precertification program that could replace the need for a premarket submission in some cases and allow for decreased submission content and/or faster review of marketing applications for software products in other cases. During the pilot program, FDA customers, including pilot participants, will have the opportunity to provide input on the development of the precertification program.

Blackburn represents Tennessee’s Seventh Congressional District in the U.S. House of Representatives.

For more information on the FDA’s pilot program, click here.



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