This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Council of the European Communities (CED). Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. http://data.europa.eu/eli/dir/1993/42/oj (CEC, 1993).
US Food and Drug Administration (FDA). Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf (FDA, 2009).
Independent Medicines and Medical Devices Safety Review (IMMDSReview). First Do Not Harm—The Report of the Independent Medicines and Medical Devices Safety Review (IMMDSReview, 2020).
FDA. Draft Guidance: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation (FDA, 2020).
Center for Devices and Radiological Health (CDRH). CDRH Strategic Priorities 2016-2017: Value and Use of Patient Reported Outcomes (PROs) in Assessing Effects of Medical Devices (CDRH, 2017).
FDA. 2020 Device Approvals (FDA, 2020).
Calvert, M. et al. JAMA 319, 483–494 (2018).
Chalmers, I. & Glasziou, P. The Lancet 374, 86–89 (2009).
International Society for Quality of Life Research (ISOQOL). User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice (ISOQUOL, 2011).
Calvert, M. et al. Health Qual. Life Outcomes 11, 184 (2013).
Author information
Authors and Affiliations
Contributions
S.C.R., A.P.D. and M.J.C. conceived the idea for this article; S.C.R. developed the first draft; and all authors made substantial revisions and approved the final manuscript.
Corresponding author
Ethics declarations
Competing interests
O.L.A. receives funding from the NIHR Birmingham Biomedical Research Centre, NIHR Applied Research Centre, West Midlands, at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences Ltd. and Janssen Pharmaceuticals, Inc. O.L.A. declares personal fees from Gilead Sciences Ltd., GlaxoSmithKline (GSK) and Merck outside the submitted work. M.J.C. is director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for Patient Reported Outcomes Research and a National Institute for Health Research (NIHR) Senior Investigator. M.J.C. receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB and GSK Pharma. M.J.C. has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Aparito Ltd., CIS Oncology, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. The other authors declare no competing interests. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care or the MHRA.
Rights and permissions
About this article
Cite this article
Cruz Rivera, S., Dickens, A.P., Aiyegbusi, O.L. et al. Patient-reported outcomes in the regulatory approval of medical devices. Nat Med 27, 2067–2068 (2021). https://doi.org/10.1038/s41591-021-01546-9
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41591-021-01546-9
This article is cited by
-
Response shift in coronary artery disease
Quality of Life Research (2024)
-
Recommendations to address respondent burden associated with patient-reported outcome assessment
Nature Medicine (2024)