Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation: guidance for industry and Food and Drug Administration staff, and other stakeholders
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval Patient Reported Outcome Measures United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- The U.S. Food and Drug Administration (FDA or the Agency) encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices. Patients’ perspectives on living with their health condition and its treatment or management are most useful in medical device evaluation when they are relevant to the regulatory decision and reliably measured. Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel, function, and survive as valid scientific evidence to support the regulatory and healthcare decision-making process. By integrating patients’ voices throughout the total product life cycle (TPLC), concepts important to patients can be considered in the evaluation and surveillance of medical devices. The objectives of this guidance are to: 1. Describe principles that may be considered when using PRO instruments in the evaluation of medical devices (Section IV); 2. Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose (Section IV), and; 3. Outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach (Section V). This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series, led by FDA’s Center for Drug Evaluation and Research (CDER) and CBER.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (13 pages)).
- NLM Unique ID:
- 9918351274306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351274306676