Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff humanitarian device exemption regulation, questions and answers. by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus.…”
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Modifications to devices subject to premarket approval (PMA) the PMA supplement decision-making process. by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Testing.…”
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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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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... by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Inspection United States.…”
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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.)

Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

Subjects: “…Medical instruments and apparatus Government policy United States.…”
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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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Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

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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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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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Public health notifications by Center for Devices and Radiological Health (U.S.)

Subjects: “…Medical instruments and apparatus Safety measures.…”
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Guidance for industry "help-seeking" and other disease awareness communications by or on behalf of drug and device firms. by Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), Center for Devices and Radiological Health (U.S.)

Subjects: “…Advertising Medical instruments and apparatus United States.…”
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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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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.)

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User fees and refunds for premarket notification submissions (510(k)s) by Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)

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