Medical device design innovation from concept to market / by Ogrodnik, Peter J., Books24x7, Inc

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Medicare lack of price transparency may hamper hospitals' ability to be prudent purchasers of implantable medical devices : report to the Chairman, Committee on Finance, U.S. Senat... by United States. Government Accountability Office, United States. Congress. Senate. Committee on Finance

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Medical device approval and regulation in 16 countries : brief overviews / by PALCI EBSCO books

Subjects: “…Medical instruments and apparatus Safety regulations.…”
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Guidance for industry and FDA staff expedited review of premarket submissions for devices. by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus United States Evaluation.…”
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Annual reports for approved premarket approval applications (PMA) by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Evaluation United States.…”
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Annual report by Center for Devices and Radiological Health (U.S.). Office of Science and Engineering Laboratories

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Guidance for industry cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs). by Center for Biologics Evaluation and Research (U.S.)

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Real-time premarket approval application (PMA) supplements by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Premarket approval application modular review by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Premarket approval application filing review by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Guidance for FDA reviewers premarket notification submissions for transfer sets (excluding sterile connecting sets). by Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Examining improvements to the regulation of medical technologies : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One... by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

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Premarket assessment of pediatric medical devices by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus United States Evaluation.…”
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Annual report by Center for Devices and Radiological Health (U.S.). Office of Device Evaluation

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Guidance for industry and FDA staff interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements. by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus United States Evaluation.…”
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Bundling multiple devices or multiple indications in a single submission by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus United States Evaluation.…”
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FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

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New medical devices invention, development, and use / by ProQuest Ebook Subscriptions, ProQuest (Firm)

Subjects: “…Medical instruments and apparatus Evaluation Congresses.…”
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Food and Drug Administration limited available data indicate that FDA has been meeting some goals for review of medical device applications : report to congressional committees. by United States. Government Accountability Office

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