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2010-01-20
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Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications; Availability
Notices
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D09002ee1bdd24c15
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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time.
75 FR 3238
https://www.govinfo.gov/app/details/FR-2010-01-20/2010-990
2010-990
FR20JA10-76
4160-01-S
Docket No. FDA-2009-D-0559
https://www.govinfo.gov/app/details/FR-2010-01-20/2010-990
https://www.govinfo.gov/content/pkg/FR-2010-01-20/html/2010-990.htm
https://www.govinfo.gov/content/pkg/FR-2010-01-20/pdf/2010-990.pdf
1 p.
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75 FR 3238
Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications; Availability; Federal Register Vol. 75, Issue
NOTICE
2010-990
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2009-D-0559
4160-01-S
2010-990
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by April 20, 2010.
Carolyn D. Vaughan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1230, Silver Spring, MD 20993, 301-796- 6338.
dsmica@fda.hhs.gov
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 75, no. 12
Office of the Federal Register, National Archives and Records Administration
2010-01-20
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216 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2010-01-20
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https://www.govinfo.gov/app/details/FR-2010-01-20
https://www.govinfo.gov/content/pkg/FR-2010-01-20/pdf/FR-2010-01-20.pdf
https://www.govinfo.gov/content/pkg/FR-2010-01-20/xml/FR-2010-01-20.xml
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