United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2006_register
executive
2010-09-22
article
Draft Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability
Notices
D09002ee1bde2492b
D09002ee1bde249a6
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.'' It was developed as a special control to support the reclassification of intervertebral body fusion devices that contain bone grafting material from class III (premarket approval) into class II (special controls). This draft guidance document describes a means by which these intervertebral body fusion devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the intervertebral body fusion device that contains bone grafting material from class III into class II (special controls) and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. This draft guidance is not final, nor is it in effect at this time.
71 FR 6778
https://www.govinfo.gov/app/details/FR-2006-02-09/E6-1735
E6-1735
fr09fe06-61
4160-01-S
Docket No. 2006D-0020
https://www.govinfo.gov/app/details/FR-2006-02-09/E6-1735
https://www.govinfo.gov/content/pkg/FR-2006-02-09/html/E6-1735.htm
https://www.govinfo.gov/content/pkg/FR-2006-02-09/pdf/E6-1735.pdf
2 p.
6778
6779
71 FR 6778
Draft Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability; Federal Register Vol. 71, Issue
NOTICE
E6-1735
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2006-05-10
Docket No. 2006D-0020
4160-01-S
E6-1735
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.'' It was developed as a special control to support the reclassification of intervertebral body fusion devices that contain bone grafting material from class III (premarket approval) into class II (special controls). This draft guidance document describes a means by which these intervertebral body fusion devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the intervertebral body fusion device that contains bone grafting material from class III into class II (special controls) and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. This draft guidance is not final, nor is it in effect at this time.
Submit written or electronic comments on this draft guidance by May 10, 2006.
Jodi N. Anderson, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036, ext. 186.
Reports and guidance documents; availability, etc.:
Intervertebral body fusion device; Class II special controls,
http://www.fda.gov/cdrh
http://www.fda.gov/cdrh/guidance.html
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets
Federal Register
Vol. 71, no. 27
Office of the Federal Register, National Archives and Records Administration
2006-02-09
continuing
daily
deposited
born digital
321 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2006-02-09
P0b002ee18094785b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr09fe06
https://www.govinfo.gov/app/details/FR-2006-02-09
https://www.govinfo.gov/content/pkg/FR-2006-02-09/pdf/FR-2006-02-09.pdf
https://www.govinfo.gov/content/pkg/FR-2006-02-09/xml/FR-2006-02-09.xml
fdlp
6661
6971
DGPO
2010-09-22
2023-05-03
FR-2006-02-09
machine generated
eng
FR
FR-2006-02-09
71
27