United States Government Publishing Office
publisher
pbl
distributor
dst
United States
Health and Human Services Department
Food and Drug Administration
author
aut
Government Organization
text
government publication
eng
GOVPUB
Executive Agency Publications
executive
2023-06-06
Health and Human Services Department
2008-01-01
monographic
harvested
born digital
29 digital object pages
HE 20.4802:H 88
https://www.govinfo.gov/app/details/GOVPUB-HE20_4000-PURL-LPS111189
P0b002ee1bea89139
000637083
https://purl.fdlp.gov/GPO/LPS111189
(OCoLC)318120269
DGPO
2023-06-06
2026-07-01
GOVPUB-HE20_4000-PURL-LPS111189
machine generated
eng
fdlp
HE20_4000
GOVPUB-HE20_4000-PURL-LPS111189
PURL-LPS111189
GOVPUB
This content was harvested from online sources of the original hosting or authoring agency and may not reflect current policy. As Federal agencies add publications to their websites, or report new publications to GPO per statutory mandate (44 U.S.C. ยงยง 1710, 1902-1903), GPO ensures long-term preservation of and access to the content.
2008
PERM_INGEST_04282022
LPS111189
https://www.govinfo.gov/app/details/GOVPUB-HE20_4000-PURL-LPS111189
https://www.govinfo.gov/content/pkg/GOVPUB-HE20_4000-PURL-LPS111189/pdf/GOVPUB-HE20_4000-PURL-LPS111189.pdf
Draft Guidance for Hde Holders, Institutional Review Boards (Irbs), Clinical Investigators, and FDA Staff
Humanitarian Device Exemption Regulation, Questions and Answers
Medical instruments and apparatus
0499-T-02 (online)
Center for Devices and Radiological Health (U.S.)
Center for Biologics Evaluation and Research (U.S.)
mdu
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
[2008]
monographic
20 pages : digital, PDF file
HE 20.4802:H 88
0499-T-02 (online)
text
eng
Title from PDF title page (viewed on Apr. 9, 2009).
"August 5, 2008."
Mode of access: Internet at the FDA CDER Web site. Address as of 4/09/09: http://www.fda.gov/cdrh/ode/guidance/1668.pdf ; current access is available via PURL.
Medical instruments and apparatus
https://purl.fdlp.gov/GPO/LPS111189
https://catalog.gpo.gov/fdlpdir/locate.jsp?ItemNumber=0499-T-02&SYS=000637083
Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff
humanitarian device exemption regulation, questions and answers
Humanitarian device exemption regulation, questions and answers
Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff
Humanitarian device exemption regulation, questions and answers
humanitarian device exemption regulation, questions and answers