Humanitarian device exemption (HDE) program: guidance for industry and Food and Drug Administration staff

Humanitarian device exemption (HDE) program: guidance for industry and Food and Drug Administration staff

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.
United States. Food and Drug Administration. Office of Clinical Policy and Programs. Office of Orphan Product Development, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2019
Language(s):
English
Format:
Text
Subject(s):
Compassionate Use Trials -- standards
Device Approval -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (iii, 54 pages)).
NLM Unique ID:
101760408 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101760408