Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, 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):
- Clinical Studies as Topic Device Approval Patient Participation 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) values the experience and perspectives of patients and their caregivers. FDA believes that these individuals can and should be able to provide their insights about a disease or condition, including living with that disease/condition, and the impact of medical devices in the diagnosis, treatment, and management of the disease/condition, through engagement activities. Patient advisors serving in an advisory or consultative capacity can share their experiences living with a medical condition to help improve clinical study design and conduct, without participating in the research study themselves as explained in more detail below. This guidance is intended to: (1) help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors (see definition in Section IV) to improve the design and conduct of medical device clinical studies; (2) highlight the benefits of engaging with patient advisors early in the medical device development process; (3) illustrate which patient engagement activities are generally not considered by FDA to constitute research or an activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs); and (4) address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (11 pages)).
- NLM Unique ID:
- 9918351274406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351274406676