FDA’s Total Product Life Cycle Advisory Program (TAP) continues to expand, giving more medical device innovators the opportunity for earlier, more frequent engagement with FDA during development. As of FDA’s July 2026 TAP update, the program has expanded across all Offices of Health Technologies (OHTs) for qualifying Breakthrough-designated and Safer [...]

On July 10, 2026, FDA issued a proposed rule that would modernize drug manufacturing registration requirements. If finalized, the rule would create a streamlined registration pathway for distributed manufacturing establishments operating under a hub-and-spoke model. FDA also says the rule would clarify registration requirements for certain foreign establishments that manufacture [...]

On June 29, 2026, FDA announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to advance U.S. drug manufacturing and improve regulatory predictability for new domestic pharmaceutical manufacturing facilities. The program is designed to give FDA earlier visibility into facility design, [...]

On May 29, 2026, FDA issued its final guidance, “Content of Human Factors Information in Medical Device Marketing Submissions.” The guidance provides a risk-based framework for determining what human factors information should be documented and included in medical device marketing submissions, including 510(k)s, De Novo requests, PMAs, and HDE applications. [...]