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  • Proceedings of the First International Conference of Medical Device Regulatory Authorities (ICMDRA), June 2-6, 1986 / World Health Organization, Pan American Health Organization, Food & Drug Administration.

    • Text
    • Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1987]
    • 1987

  • Silicone in medical devices [microform] : conference proceedings : February 1-2, 1991, Baltimore, Maryland / project officer, Melvin E. Stratmeyer.

    • Text
    • Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Springfield, VA : National Technical Information Service [distributor, 1991]
    • 1991

  • The selection of patients for X-ray examinations : dental radiographic examinations / Lireka P. Joseph and the Dental Radiographic Patient Selection Criteria Panel.

    • Text
    • Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1987]
    • 1987

  • Medical devices used in home health care [microform]

    • Text
    • Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1992]
    • 1992

  • Implementing the Mammography Quality Standards Act (MQSA) of 1992 [microform] : roles in improving mammography services : conference proceedings, September 20-22, 1993, Reston, Virginia.

    • Text
    • Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1994]
    • 1994

  • Division of small manufacturers, international and consumer assistance (DSMICA).

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [2002?]
    • 2002

  • User fees and refunds for premarket approval applications.

    • Text
    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110430

  • Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.

    • Text
    • [Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; [Rockville, Md.] : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS110580

  • Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.

    • Text
    • [Silver Spring, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Rockville, MD : Center for Biologics Evaluation and Research, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111189

  • Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner : Center for Devices and Radiological Health (CDRH) : Center for Drug Evaluation and Research (CDER), [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111001

  • Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.

    • Text
    • [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]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111915

  • Guidance for industry : FDA export certificates.

    • Text
    • 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]
    • 2005
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113005

  • Annual reports for approved premarket approval applications (PMA).

    • Text
    • 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]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112503

  • Bundling multiple devices or multiple indications in a single submission.

    • Text
    • 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, [2007]
    • 2007
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112429

  • FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment.

    • Text
    • 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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113026

  • FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals.

    • Text
    • [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]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113041

  • Guidance for industry and FDA staff : expedited review of premarket submissions for devices.

    • Text
    • 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]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111920

  • Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.

    • Text
    • 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, [2008]
    • 2008
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS111964

  • Guidance for clinical trial sponsors : establishment and operation of clinical trial data monitoring committees.

    • Text
    • 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, [2006]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112814

  • Guidance for industry and staff : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA.

    • Text
    • [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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112907

  • Guidance for clinical trial sponsors : on the establishment and operation of clinical trial data monitoring committees.

    • Text
    • 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, [2001]
    • 2001
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113180

  • Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria.

    • Text
    • 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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112954

  • Premarket approval application modular review.

    • Text
    • 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]
    • 2003
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113037

  • Premarket assessment of pediatric medical devices.

    • Text
    • [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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113057

  • Premarket approval application filing review.

    • Text
    • [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]
    • 2003
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113061

  • Real-time premarket approval application (PMA) supplements.

    • Text
    • 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]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112750

  • 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.

    • Text
    • [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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112835

  • Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use.

    • Text
    • [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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS112905

  • User fees and refunds for premarket notification submissions (510(k)s).

    • Text
    • [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]
    • 2004
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113018

  • User fees and refunds for premarket approval applications.

    • Text
    • 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]
    • 2003
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113032

  • Guidance for industry [electronic resource] : pharmacogenomic data submissions, companion evidence.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : National Center for Toxicological Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Research, [2007]
    • 2007
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113323

  • Guidance for industry [electronic resource] : pharmacogenomic data submissions.

    • Text
    • 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, [2005]
    • 2005
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113396

  • Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical product development to support labeling claims.

    • Text
    • 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, [2006]
    • 2006
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113413

  • Guidance for industry [electronic resource] : somatic cell therapy for cardiac disease.

    • Text
    • 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, [2009]
    • 2009
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113577

  • Guidance for industry and FDA staff [electronic resource] : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.

    • Text
    • [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]
    • 2008
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS111915

  • User fees and refunds for premarket approval applications [electronic resource].

    • Text
    • 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]
    • 2003
    • 1 Resource

    Available Online

    http://purl.access.gpo.gov/GPO/LPS113032

  • Guidance for industry : pharmacogenomic data submissions.

    • Text
    • 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, [2005]
    • 2005
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS113396

  • Information sheet guidance for IRBs, clinical investigators, and sponsors : significant risk and nonsignificant risk medical device studies.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, [2006]
    • 2006
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS114992

  • Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms.

    • Text
    • Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001]
    • 2001
    • 1 Resource

    Available Online

    https://purl.fdlp.gov/GPO/LPS115334

  • Extremity radiography following trauma : an overview / Lireka P. Joseph, Mary Ann Wollerton.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1984.
    • 1984
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:Ex 8Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Therapeutic microwave and shortwave diathermy : a review of thermal effectiveness, safe use, and state of the art, 1984 / Luther Kloth, Mary Ann Morrison.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1985.
    • 1985
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:D 54/2Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Optical radiation emissions from selected sources.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1980-
    • 1980-present
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:Op 4/pt.2 pt.2Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Assessment and modification of clinical utility in diagnostic radiology : the oral cholecystogram and the upper gastrointestinal examinations / principal investigator, Keith I. Marton.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1985.
    • 1985
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:D 54/4Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Computer program for absorbed dose to the breast in mammography / Linda W. Andersen and Marvin Rosenstein.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1985.
    • 1985
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:C 73Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Behavioral effects of microwave radiation absorption / editors, John C. Monahan, John A. D'Andrea.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1985.
    • 1985
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:M 58/2Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Patient exposure reduction during scoliosis radiography / Priscilla F. Butler [and others].

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1985]
    • 1985
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:Sco 4Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Basic concepts in the selection of patients for dental X-ray examinations / Sharon L. Brooks, Lireka P. Joseph.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., [1985]
    • 1985
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:P 27/5Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Laser light show safety : who's responsible?.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1986]
    • 1986
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:L 33Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Medical device Federal Register documents, June 4, 1976 through April 8, 1986 / prepared by Division of Small Manufacturers Assistance, Office of Training and Assistance; project officer Arthur C. Kohler.

    • Text
    • Rockville, Md. : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1986.
    • 1986
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:M 46/5Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • Medical device establishment registration : information and instructions.

    • Text
    • [Silver Spring, Md.] : U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1987]
    • 1987
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4602:M 46/6Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

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