FDA calls for stakeholders to join MDUFA talks
The US Food and Drug Administration (FDA) on Thursday called for non-industry stakeholders, including patient and consumer advocacy groups, to declare their interest in participating in consultation meetings for the next iteration of the Medical Device User Fee Amendments (MDUFA V) by 26 February 2021.The monthly consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin next month. “FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions,” FDA wrote in the Federal Register notice requesting the groups’ participation.
The MDUFA V negotiations are off to a late start after the COVID-19 pandemic forced FDA to postpone its public kickoff meeting from April to October of last year. With the current agreement set to expire in September 2022, FDA and industry have a limited amount of time to reach an agreement and pass recommendations for MDUFA V on to Congress. (RELATED: MDUFA V: Industry wants fine tuning while FDA seeks expansion, Regulatory Focus 27 October 2020).
During the MDUFA IV negotiations, FDA held 11 stakeholder meetings and 13 industry discussion sessions between September 2015 and August 2016.
Federal Register Notice