Documents and comments received by the Dockets Management Branch "MAY" be posted on the Internet. Please "DO NOT INCLUDE" personal identifying information, i.e. date of birth, social security number, medical information, etc., in your correspondence. Documents are on display for public inspection at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; TTY/TDD Users 1-800-735-2258.
NOTICES-FINAL GUIDANCES
Docket No. 2004D-0371, CDRH 200436. Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan; Availability. Pages 57034-57035 [FR Doc. 04-21317] [TXT] [PDF] [PRE-PUB] Comments by September 23, 2005The Guidance PDF Version
The Guidance Word Version
NOTICES
Docket No. 2004N-0408, CBER 200425. Regulatory Site Visit Training Program. Pages 57033-57034 [FR Doc. 04-21318] [TXT] [PDF] [PRE-PUB] electronic requests for participation by October 25, 2004
FINAL RULES
Docket No. 2004N-0370, CDRH 200437. Medical Devices; Immunology and Microbiology Devices; Classification of the Beta-Glucan Serological Assay. Pages 56934-56936 [FR Doc. 04-21316] [TXT] [PDF] [PRE-PUB] Effective October 25, 2004