Least Burdensome Medical Device Regulation is Producing Results, Gottlieb Says

FDA Commissioner Scott Gottlieb updated the House Energy and Commerce Committee on the agency’s progress in implementing the 21st Century Cures Act in regards to medical devices, noting the agency continues to apply the act’s concept of least burdensome regulation towards medical devices and has seen positive results.

CDRH has taken the Cures Act’s expansion of least burdensome device regulation and used it as a focal point for medical device regulation, resulting in speedier review times and better quality applications from sponsors in the last few years, Gottlieb said, in testimony at the July 25 hearing.

For example, he said, the center used the Cures Act’s provisions for streamlined authority to exempt more than 70 Class I device types and over one thousand Class II two device types from the requirement to submit a 510(k) after a premarket review is deemed unnecessary to provide assurance of safety and efficacy.