Health Canada needs to act on laboratory-developed diagnostics

Health Canada needs to act on laboratory-developed diagnostics

Accepted version

Peer-reviewed

Repository URI

https://www.repository.cam.ac.uk/handle/1810/301030

Repository DOI

https://doi.org/10.17863/CAM.48107

Files

Accepted version (211.5 KB)

Type

Authors

Holloway, Kelly

Miller, Fiona A

Rousseau, François

Gutierrez, Alberto

Hogarth, Stuart

https://orcid.org/0000-0001-6796-8815

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.

Keywords

Canada, Diagnostic Test Approval, Health Policy, Humans, Legislation, Medical, Molecular Diagnostic Techniques

Journal Title

Canadian Medical Association Journal

Journal ISSN

0820-3946
1488-2329

Volume Title

191

Publisher

Joule Inc.

Publisher DOI

https://doi.org/10.1503/cmaj.190550

Rights and licensing

All rights reserved

Except where otherwised noted, this item's license is described as All rights reserved

Sponsorship

European Research Council (716689)

Collections

University of Cambridge Research Outputs (Articles and Conferences)