Third-year medical student at the Mayo Clinic Alix School of Medicine in Scottsdale, Arizona.
Adjunct faculty member in the Arizona State University (ASU) College of Health Solutions and an affiliated scholar in ASU's Center for Healthcare Delivery and Policy in Phoenix.
AMA J Ethics. 2021 Sep 1;23(9):E712-720. doi: 10.1001/amajethics.2021.712.
This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts by the FDA to strengthen device oversight and address areas of concern.
本文考察了美国食品和药物管理局（FDA）对设备监管的历史。达金盾宫内节育器导致的伤害引发了重大监管变革。本文总结了这些变革，以及 FDA 为加强设备监管和解决关注领域所做的持续努力。
