Humanitarian Device Exemption

Results: 101



#Item
41Pharmaceutical sciences / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Title 21 of the Code of Federal Regulations / Institutional review board / Humanitarian Device Exemption / Food and Drug Administration / Medicine / Health

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration[removed]New Hampshire Avenue

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-12-05 18:33:29
42Technology / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Medical device / Premarket approval / Humanitarian Device Exemption / Title 21 of the Code of Federal Regulations / Food and Drug Administration / Medicine / Health

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration[removed]New Hampshire Avenue

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-12-05 18:32:49
43Technology / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Title 21 CFR Part 11 / Investigational Device Exemption / Medical device / Center for Devices and Radiological Health / Abbreviated New Drug Application / Humanitarian Device Exemption / Food and Drug Administration / Medicine / Health

8773 Federal Register / Vol. 68, No[removed]Tuesday, February 25, [removed]Notices ADDRESSES) written or electronic comments on the draft guidance. Submit a single copy of electronic comments to

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Source URL: www.gpo.gov

Language: English - Date: 2010-12-01 14:53:33
44Health / Center for Devices and Radiological Health / Medical device / Premarket approval / Regulatory affairs / Humanitarian Device Exemption / Food and Drug Administration / Medicine / Technology

CDRH: Priorities, Challenges and Goals for the Coming Year

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Source URL: www.afdo.org

Language: English - Date: 2012-02-13 06:40:28
45Clinical research / Premarket approval / Investigational Device Exemption / Government procurement in the United States / Humanitarian Device Exemption / Food and Drug Administration / Pharmaceutical sciences / Medicine

Part 3--Fees Relating to Devices (Redline of proposed amendments)

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Source URL: www.fda.gov

Language: English
46Technology / Medical device / Federal Food /  Drug /  and Cosmetic Act / Title 21 of the Code of Federal Regulations / Humanitarian Device Exemption / Adverse event / Center for Devices and Radiological Health / Adverse effect / Premarket approval / Medicine / Food and Drug Administration / Health

DEPARTMENT OF HEALTH & HUMAN SERVICES Iublic Inenth Service Food and Dtig AdminiirMation

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-12-05 18:38:34
47Technology / Premarket approval / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Medical device / Title 21 of the Code of Federal Regulations / Humanitarian Device Exemption / Parts Manufacturer Approval / Investigational Device Exemption / Food and Drug Administration / Medicine / Health

Attachment B CDRH Draft Guidance Cover Sheet

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Source URL: www.fda.gov

Language: English
48Pharmacology / Health / Cardiology / Clinical research / Pharmaceutical industry / Humanitarian Device Exemption / Ventricular outflow tract / Clinical trial / Medicine / Pharmaceutical sciences / Food and Drug Administration

Medical Device Trial Design for the Business Professional: Lessons Learned

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Source URL: www.fda.gov

Language: English
49Premarket approval / Medical device / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Humanitarian Device Exemption / Vagus nerve stimulation / Investigational Device Exemption / Federal Food /  Drug /  and Cosmetic Act / Medicine / Food and Drug Administration / Technology

Microsoft PowerPoint - Malvina Eydelman 091010GrayScale.pptx

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Source URL: www.fda.gov

Language: English
50Medical device / Title 21 of the Code of Federal Regulations / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Adverse effect / Humanitarian Device Exemption / Premarket approval / Medicine / Food and Drug Administration / Health

APPROVAL ORDER p. DEPARTMENT OF HEALTH & HUMAN SERVICES

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2013-12-05 18:30:55
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