Congress Takes Aim at FDA's Regulatory Powers
Tuesday, April 28, 2015
Source: mHealth News
Legislators are once again seeking to limit what medical software and apps the U.S. Food and Drug Administration would be able to regulate.
Sens. Michael Bennett (D-Colo.) and Orrin Hatch (R-Utah) have re-introduced the Medical Electronic Data Technology for Consumers' Health (MEDTECH) Act. The bill was originally introduced last year, surfaced again this past January, then appeared in Congress this week in what its sponsors say is a more slimmed down version.
"We've worked to tighten the definitions for the different types of medical software that would be excluded from regulation based on feedback we've received from stakeholders and the FDA," an assistant to Hatch toldPolitico. "We also clarify the regulation of products with multiple functionality that have some components that would be regulated and others that would not."