In The Media…
U.S. Food & Drug Administration
February 14, 2022
We are pleased to see new guidance from the U.S. Food and Drug Administration supports patient engagement to help improve clinical study design for medical devices. The patient voice should play an important role in every step of the design and conduct of clinical studies.
GUIDANCE DOCUMENT
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
JANUARY 2022
FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. FDA believes medical device clinical studies designed with patient input may help to address common challenges faced in medical device clinical studies. While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies.
Read the guidance on fda.gov.
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
GUIDANCE DOCUMENT
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
JANUARY 2022
FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. FDA believes medical device clinical studies designed with patient input may help to address common challenges faced in medical device clinical studies. While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies.
Read the guidance on fda.gov.