Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings.

ABSTRACT: In an age of biomedicalization, medical devices have become more common and more technologically complicated, and adverse events associated with medical devices have increased. The U.S. Food and Drug Administration (FDA) relies on advisory panels to assist in regulatory decision making regarding medical devices. Public meetings held by these advisory panels allow stakeholders to testify, presenting evidence and recommendations, according to careful procedural standards. This research examines the participation of six stakeholder groups (patients, advocates, physicians, researchers, industry representatives and FDA representatives) in FDA panel meetings focused on the safety of implantable medical devices between 2010-2020. We use qualitative and quantitative methods to analyze speakers' op

SUBMITTER: White SK 

PROVIDER: S-EPMC9934387 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature