Postmarket Surveillance Orders Expected To Follow Final Rule
This article was originally published in The Gray Sheet
Executive Summary
The Center for Devices and Radiological Health plans to issue new orders for postmarket surveillance in several device areas soon after issuing a final rule on the Safe Medical Devices Act Sec. 522 provision.
You may also be interested in...
"Real World" Data Required On Vascular Closure Devices, CDRH Advises
CDRH's Office of Surveillance and Biometrics plans to collaborate with Duke University's Center for Education and Research on Therapeutics (CERT) on a large population study of arteriotomy closure devices.
"Real World" Data Required On Vascular Closure Devices, CDRH Advises
CDRH's Office of Surveillance and Biometrics plans to collaborate with Duke University's Center for Education and Research on Therapeutics (CERT) on a large population study of arteriotomy closure devices.
AneuRx Is First Sec. 522 Study Ordered Under Proposed Rule; More To Follow
Medtronic's AneuRx abdominal aortic aneurysm (AAA) endovascular graft will aim to compare long-term outcomes of the device's IDE cohort with patients who received the implant postmarket.