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2010-09-23
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Medical Devices; Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry; Availability
Notices
D09002ee1bded9214
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United States
Department of Health and Human Services
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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 announcing the availability of the guidance entitled ``Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry.'' This document encourages manufacturers of approved conventional cardiac ablation catheters to submit supplements to broaden their labeling from arrhythmia-specific indications to a generic arrhythmic treatment indication. The Center for Devices and Radiological Health (CDRH) is issuing this guidance document to allow companies to label these products for a broader indication without submitting additional clinical information. This recommendation is based on a comprehensive search of the medical literature.
67 FR 44218
https://www.govinfo.gov/app/details/FR-2002-07-01/02-16449
02-16449
fr01jy02-83
4160-01-S
Docket No. 01D-0519
https://www.govinfo.gov/app/details/FR-2002-07-01/02-16449
https://www.govinfo.gov/content/pkg/FR-2002-07-01/html/02-16449.htm
https://www.govinfo.gov/content/pkg/FR-2002-07-01/pdf/02-16449.pdf
2 p.
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67 FR 44218
Medical Devices; Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry; Availability; Federal Register Vol. 67, Issue
NOTICE
02-16449
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 01D-0519
4160-01-S
02-16449
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry.'' This document encourages manufacturers of approved conventional cardiac ablation catheters to submit supplements to broaden their labeling from arrhythmia-specific indications to a generic arrhythmic treatment indication. The Center for Devices and Radiological Health (CDRH) is issuing this guidance document to allow companies to label these products for a broader indication without submitting additional clinical information. This recommendation is based on a comprehensive search of the medical literature.
Submit written or electronic comments on the guidance at any time. General comments on agency guidance documents are welcome at any time.
Lesley L. Ewing, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320.
Reports and guidance documents; availability, etc.:
Medical devices, cardiac ablation catheters generic arrhythmia indications for use,
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. 67, no. 126
Office of the Federal Register, National Archives and Records Administration
2002-07-01
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346 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2002-07-01
P0b002ee1809ec8ee
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr01jy02
https://www.govinfo.gov/app/details/FR-2002-07-01
https://www.govinfo.gov/content/pkg/FR-2002-07-01/pdf/FR-2002-07-01.pdf
https://www.govinfo.gov/content/pkg/FR-2002-07-01/xml/FR-2002-07-01.xml
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2010-09-23
2023-05-04
FR-2002-07-01
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FR-2002-07-01
67
126