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Congressman Gene Green

Representing the 29th District of Texas

Rep. Green Applauds FDA’s Pilot Program to Advance Digital Healthcare

July 27, 2017
Press Release

WASHINGTON, DC — Today, Congressman Green (D-TX), Ranking Member of the Energy & Commerce Subcommittee on Health praised the FDA’s launch of its Pre-Cert for Software Pilot Program. The program builds on legislation that Rep. Green and Rep. Blackburn (R-TN) introduced in the 114th Congress – The SOFTWARE Act – which eventually became law as part of the 21st Century Cures Act in late 2016.

The FDA program will modify 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.

“As new technologies emerge, it’s important that federal regulatory agencies like the FDA are properly equipped to provide a common sense level of oversight that is appropriate for the characteristics of the product,” said Green. “This pilot program builds on the progress made by the FDA in their recently released guidance documents and gives certainty to innovators so we can unleash the next generation of health information technology.”

“Americans today lean on apps for everything from scheduling to grocery shopping to entertainment,” said Blackburn. “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.”