The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.

House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.

US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.