Health Canada needs to act on laboratory-developed diagnostics
Accepted version
Peer-reviewed
Repository URI
Repository DOI
Change log
Authors
Holloway, Kelly
Miller, Fiona A
Rousseau, François
Gutierrez, Alberto
Abstract
An international exposé of flawed regulations for medical implants prompted Canada’s health minister to announce sweeping changes to the regulation of medical devices.1 Yet an important subset of medical devices remains outside the purview of this regulatory overhaul: laboratory-developed tests.
Description
Keywords
Canada, Diagnostic Test Approval, Health Policy, Humans, Legislation, Medical, Molecular Diagnostic Techniques
Journal Title
Canadian Medical Association Journal
Conference Name
Journal ISSN
0820-3946
1488-2329
1488-2329
Volume Title
191
Publisher
Joule Inc.
Publisher DOI
Rights
All rights reserved
Sponsorship
European Research Council (716689)