Tags

Type your tag names separated by a space and hit enter

Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
Food Drug Law J. 2011; 66(3):377-404, ii.FD

Abstract

Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device innovation. However, these competing objectives have proven too difficult to reconcile. Premarket regulations not only impose a substantial burden on device manufacturers, patients, and FDA itself, they also threaten the advancement of new device technologies. This Article provides an in-depth look at the costs of FDA's current regulatory system, and suggests that these costs ultimately outweigh the system's benefits. Therefore, it proposes that the U.S. consider a new approach to device regulation--one that focuses primarily on postmarket surveillance, and allows end-users, such as health care providers and professional medical organizations, to take a more prominent role.

Authors+Show Affiliations

Emory University, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24505854

Citation

Scott, Bonnie. "Oversight Overhaul: Eliminating the Premarket Review of Medical Devices and Implementing a Provider-centered Postmarket Surveillance Strategy." Food and Drug Law Journal, vol. 66, no. 3, 2011, pp. 377-404, ii.
Scott B. Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy. Food Drug Law J. 2011;66(3):377-404, ii.
Scott, B. (2011). Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy. Food and Drug Law Journal, 66(3), 377-404, ii.
Scott B. Oversight Overhaul: Eliminating the Premarket Review of Medical Devices and Implementing a Provider-centered Postmarket Surveillance Strategy. Food Drug Law J. 2011;66(3):377-404, ii. PubMed PMID: 24505854.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy. A1 - Scott,Bonnie, PY - 2014/2/11/entrez PY - 2011/1/1/pubmed PY - 2014/8/16/medline SP - 377-404, ii JF - Food and drug law journal JO - Food Drug Law J VL - 66 IS - 3 N2 - Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device innovation. However, these competing objectives have proven too difficult to reconcile. Premarket regulations not only impose a substantial burden on device manufacturers, patients, and FDA itself, they also threaten the advancement of new device technologies. This Article provides an in-depth look at the costs of FDA's current regulatory system, and suggests that these costs ultimately outweigh the system's benefits. Therefore, it proposes that the U.S. consider a new approach to device regulation--one that focuses primarily on postmarket surveillance, and allows end-users, such as health care providers and professional medical organizations, to take a more prominent role. SN - 1064-590X UR - https://www.unboundmedicine.com/medline/citation/24505854/Oversight_overhaul:_eliminating_the_premarket_review_of_medical_devices_and_implementing_a_provider_centered_postmarket_surveillance_strategy_ DB - PRIME DP - Unbound Medicine ER -