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1
Annual reports for approved premarket approval applications (PMA).
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2006

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Government Document Book
2
User fees and refunds for premarket approval applications.
Rockville, MD : 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

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Government Document Book
3
Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2002

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Government Document Book
4
Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs).
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007

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Government Document Book
5
Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.
[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2008

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Government Document Book
6
Guidance for industry : preparation of IDEs and INDs for products intended to repair or replace knee cartilage.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, 2007

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Government Document Book
7
Requests for inspection by an accredited person under the Inspection by Accredited Persons Program authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2005

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Government Document Book
8
Guidance for industry : class II special controls guidance document : cord blood processing system and storage container.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007

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Government Document Book
9
Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2004

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Government Document Book
10
Guidance for industry, FDA staff, and FDA-accredited third parties.
[Rockville, Md.] : [Bethesda, Md.] : 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

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Government Document Book
11
Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devises and Radiological Health : Center for Biologics Evaluation and Research, 2004

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Government Document Book
12
Guidance for FDA reviewers : premarket notification submissions for blood and plasma warmers.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2001

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Government Document Book
13
User fees and refunds for premarket notification submissions (510(k)s).
[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2004

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Book
14
FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals.
[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2008

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Book
15
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2004

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Book
16
Guidance for industry and staff : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA.
[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, 2004

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Government Document Book
17
Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, 2007

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Book
18
Guidance for industry : FDA export certificates.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Veterinary Medicine : Center for Food Safety and Applied Nutrition, 2005

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Government Document Book
19
Guidance for industry and FDA staff : expedited review of premarket submissions for devices.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2008

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Government Document Book
20
Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.
[Silver Spring, MD] : Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Center for Biologics Evaluation and Research, 2008

This item is not available through EZBorrow. Please contact your institution’s interlibrary loan office for further assistance.
Government Document Book
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