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2010-09-23
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Medical Devices; Effective Date of Requirement for Premarket Approval for a Class III Preamendments Obstetrical and Gynecological Device
Rules and Regulations
D09002ee1bdfa7cd6
D09002ee1bdfa7db5
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 issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.
65 FR 41330
https://www.govinfo.gov/app/details/FR-2000-07-05/00-16808
00-16808
fr05jy00-6
4160-01-F
Docket No. 95N-0084
https://www.govinfo.gov/app/details/FR-2000-07-05/00-16808
https://www.govinfo.gov/content/pkg/FR-2000-07-05/html/00-16808.htm
https://www.govinfo.gov/content/pkg/FR-2000-07-05/pdf/00-16808.pdf
Medical Devices
3 p.
41330
41332
65 FR 41330
Code of Federal Regulations
Title 21 Part 884
21 CFR Part 884
Medical Devices; Effective Date of Requirement for Premarket Approval for a Class III Preamendments Obstetrical and Gynecological Device; Federal Register Vol. 65, Issue
RULE
00-16808
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2000-07-05
Docket No. 95N-0084
4160-01-F
00-16808
Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.
This rule is effective July 5, 2000.
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
Medical devices:
Class III preamendments obstetrical and gynecological device; premarket approval; effective date approval,
Federal Register
Vol. 65, no. 129
Office of the Federal Register, National Archives and Records Administration
2000-07-05
continuing
daily
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238 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2000-07-05
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr05jy00
https://www.govinfo.gov/app/details/FR-2000-07-05
https://www.govinfo.gov/content/pkg/FR-2000-07-05/pdf/FR-2000-07-05.pdf
https://www.govinfo.gov/content/pkg/FR-2000-07-05/xml/FR-2000-07-05.xml
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2010-09-23
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FR-2000-07-05
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FR-2000-07-05
65
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