Contains Nonbinding Recommendations
Humanitarian Device Exemption
(HDE) Program
Guidance for Industry and
Food and Drug Administration Staff
Document issued on September 6, 2019.
The draft of this document was issued on June 13, 2018 .
For questions about this document regarding CDRH-regulated devices , contact ORP: Office of
Regulatory Programs/DRP1: Division of Submission Support , Center for Devices and
Radiological Health, at 301 -796-5640.
For questions about this document regarding CBER- regulated devices, contact the Office of
Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.
This guidance supersedes “Guidance for HDE holders, Institutional Review
Boards (IRBs), Clinical Investigators, and Food and Drug Administration
Staff, Humanitarian Device Exemptions (HDE) Regulation: Questions and
Answers,” issued July 8, 2010.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number
for this information collection is 0910-0661 (expires 09-30-2022).
See
additional PRA statement in Section I X of this guidance. U.S.
Department of Health and Human Se rvices
Food and Drug Administration
Center for Devices and Radiological Health
Center for Bi ologics Evaluation and Research
Office of Orphan Product Development
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