CORE
🇺🇦Â
 make metadata, not war
Services
Services overview
Explore all CORE services
Access to raw data
API
Dataset
FastSync
Content discovery
Recommender
Discovery
OAI identifiers
OAI Resolver
Managing content
Dashboard
Bespoke contracts
Consultancy services
Support us
Support us
Membership
Sponsorship
Community governance
Advisory Board
Board of supporters
Research network
About
About us
Our mission
Team
Blog
FAQs
Contact us
Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
Authors
AJ Rush
D Schultz
+17Â more
DB Kramer
Eunice Yu
G Roland
J Dichiara
J Hines
Jonas Zajac Hines
JP O'Reardon
JZ Hines
M Cohen
P Lurie
P Lurie
Peter Lurie
SD Ramsey
SH Lisanby
Sidney Wolfe
SS Dhruva
WH Maisel
Publication date
1 July 2010
Publisher
Public Library of Science
Doi
Cite
View
on
PubMed
Abstract
Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied
Similar works
Full text
Open in the Core reader
Download PDF
Available Versions
Public Library of Science (PLOS)
See this paper in CORE
Go to the repository landing page
Download from data provider
Last time updated on 18/09/2018
Public Library of Science (PLOS)
See this paper in CORE
Go to the repository landing page
Download from data provider
Last time updated on 05/06/2019
Directory of Open Access Journals
See this paper in CORE
Go to the repository landing page
Download from data provider
oai:doaj.org/article:f05e97165...
Last time updated on 09/08/2016
Crossref
See this paper in CORE
Go to the repository landing page
Download from data provider
info:doi/10.1371%2Fjournal.pme...
Last time updated on 11/12/2019