Importance US law generally requires testing of high-risk medical devices prior to approval,
as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring …

Objective To evaluate safety alerts and recalls, publication of key trial outcomes, and
subsequent US approval of high profile medical devices introduced in the European Union …

In September 2015, the US Food and Drug Administration (FDA) convened a meeting of the
Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of …

Background There have been numerous cases of adverse events since the introduction of
Essure medical devices for sterilization in 2002. This study analyzed the safety event reports …

Background: The postmarket surveillance system plays a vital role in managing residual
risks and identifying safety signals in real-world clinical practice. The Food and Drug …

Importance The US Food and Drug Administration (FDA) recently issued a safety warning
regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis …

Objective To assess recent high-risk ophthalmic medical device recalls. Methods The
publicly available Food and Drug Administration Center for Devices and Radiological Health …

The field of women's health has endured numerous recent controversies involving medical
devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization …

Purpose The aim of this study was to critically assess the clinical evidence leading to
radiologic medical device approvals via the premarket approval pathway from 2000 to 2015 …

Balancing sufficient medical device regulation and efficient diffusion of potentially life-saving
technology is a difficult task. Industry has argued that reducing medical device regulation …