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. 2021 Dec;27(12):2067-2068.
doi: 10.1038/s41591-021-01546-9.

Patient-reported outcomes in the regulatory approval of medical devices

Samantha Cruz Rivera  1   2 , Andrew P Dickens  3   4 , Olalekan Lee Aiyegbusi  3   4   5   6 , Rebecca Flint  7 , Camilla Fleetcroft  7 , Duncan McPherson  7 , Philip Collis  3   4   8 , Melanie J Calvert  3   4   5   6   9   10
Affiliations

Patient-reported outcomes in the regulatory approval of medical devices

Samantha Cruz Rivera et al. Nat Med. 2021 Dec.
No abstract available

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References

    1. 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).
    1. 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/GuidanceComplianceRegulatoryInformati... (FDA, 2009).
    1. 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).
    1. FDA. Draft Guidance: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation (FDA, 2020).
    1. 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).

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