Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney Disease

Michelle E Tarver; Carolyn Neuland

doi:10.2215/CJN.11510720

Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney Disease

Clin J Am Soc Nephrol. 2021 Apr 7;16(4):636-638. doi: 10.2215/CJN.11510720. Epub 2021 Mar 3.

Authors

Michelle E Tarver¹, Carolyn Neuland

Affiliation

¹ Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland.

No abstract available

Keywords: Food and Drug Administration; decision making; end stage kidney disease; patient engagement; patient preference; patient-reported outcomes; regulatory.

MeSH terms

Clinical Decision-Making*
Equipment and Supplies*
Humans
Kidney Diseases / therapy*
Patient Participation*
Patient Preference*
Therapies, Investigational*

Grants and funding

R18 FD005283/FD/FDA HHS/United States