FDA Mulls Establishing Patient Affairs Office

The FDA is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the device development process.

The agency is inviting comments for 90 days on the proposal, which responds to calls from stakeholders for more centralized patient engagement.

The office is intended to improve patient engagement in the development process across product centers — such as CDRH — with improved transparency and accessibility. It would focus on developing a better understanding of patient experiences with diseases, and on familiarizing patients and advocates with the FDA’s regulatory processes.

For the next version of MDUFA, the FDA has proposed establishing a dedicated staff to help device makers use patient input in their device development. Congress will have to craft a legislation package to reauthorize MDUFA before Oct. 1.

Read the notice here: www.fdanews.com/03-13-17-Notice.pdf. — José Vasquez