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2011-05-10
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Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant
Proposed Rules
D09002ee1bde2a50a
D09002ee1bde2a570
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is proposing to amend the classification regulations for condoms and condoms with spermicidal lubricant containing nonoxynol-9 (condoms with spermicidal lubricant) to designate a special control for natural rubber latex (latex) condoms with and without spermicidal lubricant. FDA is proposing the draft guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,'' as the special control that the agency believes will help provide a reasonable assurance of the safety and effectiveness of the devices. Elsewhere in this issue of the Federal Register, FDA is announcing a notice of availability of the draft special controls guidance document for public comment.
70 FR 69102
https://www.govinfo.gov/app/details/FR-2005-11-14/05-22611
05-22611
fr14no05-25
RIN 0910-AF21
4160-01-S
Docket No. 2004N-0556
https://www.govinfo.gov/app/details/FR-2005-11-14/05-22611
https://www.govinfo.gov/content/pkg/FR-2005-11-14/html/05-22611.htm
https://www.govinfo.gov/content/pkg/FR-2005-11-14/pdf/05-22611.pdf
17 p.
69102
69118
70 FR 69102
Code of Federal Regulations
Title 21 Part 884
21 CFR Part 884
Regulation Identification Number 0910-AF21
RIN 0910-AF21
Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant; Federal Register Vol. 70, Issue
PRORULE
05-22611
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2006-02-13
Docket No. 2004N-0556
4160-01-S
05-22611
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the classification regulations for condoms and condoms with spermicidal lubricant containing nonoxynol-9 (condoms with spermicidal lubricant) to designate a special control for natural rubber latex (latex) condoms with and without spermicidal lubricant. FDA is proposing the draft guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,'' as the special control that the agency believes will help provide a reasonable assurance of the safety and effectiveness of the devices. Elsewhere in this issue of the Federal Register, FDA is announcing a notice of availability of the draft special controls guidance document for public comment.
Submit written or electronic comments on the proposed rule by February 13, 2006. See section IV.C of this document for the proposed effective and compliance dates of a final rule based on this proposal.
Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180.
Medical devices:
Obstetrical and gynecological devices
Condom and condom with spermicidal lubricant; special control designation,
http://stats.bls.gov/oes/2003/may/naics4_339100.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
http://www.cdc.gov/nchstp/dstd/Stats_trends/trends2000.pdf
http://www.cdc.gov/nchstp/od/latex.htm
http://www.cdc/gov/nchstp/dstd/Stats_Trends/Trends2000.pdf
http://www.fda.gov/cdrh/ode/contrlab.html
http://www.fda.gov/cdrh/ode/oderp455.html
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
http://www.niaid.nih.gov/dmid/stds/condomreport.pdf
http://www.regulations.gov
Federal Register
Vol. 70, no. 218
Office of the Federal Register, National Archives and Records Administration
2005-11-14
continuing
daily
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218 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2005-11-14
P0b002ee180cfb988
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr14no05
https://www.govinfo.gov/app/details/FR-2005-11-14
https://www.govinfo.gov/content/pkg/FR-2005-11-14/pdf/FR-2005-11-14.pdf
https://www.govinfo.gov/content/pkg/FR-2005-11-14/xml/FR-2005-11-14.xml
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2011-05-10
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FR-2005-11-14
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FR-2005-11-14
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