Patient-reported outcomes in the regulatory approval of medical devices

Author:

Cruz Rivera Samantha,Dickens Andrew P.ORCID,Aiyegbusi Olalekan LeeORCID,Flint Rebecca,Fleetcroft Camilla,McPherson Duncan,Collis Philip,Calvert Melanie J.ORCID

Publisher

Springer Science and Business Media LLC

Subject

General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference10 articles.

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).

2. 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).

3. 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).

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 Draft Guidance: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation (FDA, 2020).

5. 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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