Search Results - [Dept. of Health and Human Services, Food and Drug Administration],

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  1. 1

    Information sheet guidance for IRBs, clinical investigators, and sponsors frequently asked questions about medical devices by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2006
    Description: 1 online resource (12 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health,…”
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    Information sheet guidance for IRBs, clinical investigators, and sponsors frequently asked questions about medical devices
  2. 2

    Information sheet guidance for IRBs, clinical investigators, and sponsors significant risk and nonsignificant risk medical device studies by Center for Devices and Radiological Health (U.S.)

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2006
    Description: 14 pages : digital, PDF file.
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health,…”
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    Information sheet guidance for IRBs, clinical investigators, and sponsors significant risk and nonsignificant risk medical device studies
  3. 3

    Guidance for FDA reviewers premarket notification submissions for blood and plasma warmers by Center for Biologics Evaluation and Research (U.S.)

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2001
    Description: 6 pages : digital, PDF file.
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    Guidance for FDA reviewers premarket notification submissions for blood and plasma warmers
  4. 4

    Guidance for industry use of sterile connecting devices in blood bank practices by Center for Biologics Evaluation and Research (U.S.)

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2000
    Description: i, 6 pages : digital, PDF file.
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    Guidance for industry use of sterile connecting devices in blood bank practices
  5. 5

    Guidance for industry and FDA staff devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps) by United States. Food and Drug Administration. Office of Combination Products

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, 2007
    Description: 1 electronic text : HTML file.
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    Guidance for industry and FDA staff devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps)
  6. 6

    Guidance for industry and FDA staff early development considerations for innovative combination products by United States. Food and Drug Administration. Office of Combination Products

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, 2006
    Description: 13 pages : digital, PDF file.
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    Guidance for industry and FDA staff early development considerations for innovative combination products
  7. 7

    User fees and refunds for premarket approval applications by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2003
    Description: 12 pages : digital, PDF file.
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research,…”
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    User fees and refunds for premarket approval applications
  8. 8

    Guidance for industry, FDA staff, and FDA-accredited third parties. Manufacturer's notification of the intent to use accredited person under the accredited person inspection progra... by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

    Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Center for Biologics Evaluation and Research, 2009
    Description: 1 online resource (10 pages)
    “…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Center for Biologics Evaluation and Research,…”
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    Guidance for industry, FDA staff, and FDA-accredited third parties. Manufacturer's notification of the intent to use accredited person under the accredited person inspection program authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)

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