Search Results - [Dept. of Health and Human Services, Food and Drug Administration],
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Information sheet guidance for IRBs, clinical investigators, and sponsors frequently asked questions about medical devices
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2006“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health,…”Description: 1 online resource (12 pages)
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2
Information sheet guidance for IRBs, clinical investigators, and sponsors significant risk and nonsignificant risk medical device studies
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2006“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health,…”Description: 14 pages : digital, PDF file.
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3
Guidance for FDA reviewers premarket notification submissions for blood and plasma warmers
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2001“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,…”Description: 6 pages : digital, PDF file.
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4
Guidance for industry use of sterile connecting devices in blood bank practices
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2000“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,…”Description: i, 6 pages : digital, PDF file.
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5
Guidance for industry and FDA staff devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, 2007“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products,…”Description: 1 electronic text : HTML file.
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6
Guidance for industry and FDA staff early development considerations for innovative combination products
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, 2006“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products,…”Description: 13 pages : digital, PDF file.
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7
User fees and refunds for premarket approval applications
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“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research,…”Description: 12 pages : digital, PDF file.
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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...
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“…U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Center for Biologics Evaluation and Research,…”Description: 1 online resource (10 pages)
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