Files

Download

Download Full Text (233 KB)

Document Type

Book Chapter

Publication Title

The Future of Medical Device Regulation

Description

We argue that changing how postmarket studies are conducted and who evaluates them might mitigate some concerns over the agency’s increasing reliance upon RWE. Distributing the responsibility for designing, conducting, and assessing real world studies of medical devices and drugs beyond industry sponsors and the FDA is critical to producing – and acting upon – more clinically useful information. We explore how the DESI program provides a useful model for the governance of RWE today. We explain why the FDA’s Center for Devices and Radiological Health is the most promising site for a new DESI initiative inspired by the challenges of regulating drugs in the past.

ISBN

978-1-108-83863-4

Publication Date

2022

Publisher

Cambridge University Press

Disciplines

Law | Medical Jurisprudence | Science and Technology Law

Comments

"An online version of this work is published at doi.org/10.1017/9781108975452 under a Creative Commons Open Access license CC-BY-NC-ND 4.0 which permits re-use, distribution and reproduction in any medium for non-commercial purposes providing appropriate credit to the original work is given. You may not distribute derivative works without permission. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0"

Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward

Share

COinS