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FDA's clearance of medical devices through the 510(k) process.
Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Government Document Online Book -
2
FDA medical device approval is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Ove...
Subjects: “…Medical instruments and apparatus United States Testing.…”
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Government Document Online Book -
3
Scientific disagreements regarding medical device regulatory decisions.
Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Government Document Online Book -
4
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, 2006Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Government Document Online Book -
5
Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria
Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Government Document Online Book -
6
Real-time premarket approval application (PMA) supplements
Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Government Document Online Book -
7
Premarket approval application modular review
Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Government Document Online Book -
8
FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals
Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Government Document Online Book -
9
Premarket approval application filing review
Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Government Document Online Book -
10
Guidance for FDA reviewers premarket notification submissions for transfer sets (excluding sterile connecting sets).
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2001Subjects: “…Medical instruments and apparatus Evaluation Government policy United States.…”
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Government Document Online Book -
11
Guidance for industry class II special controls guidance document : cord blood processing system and storage container.
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2007Subjects: Get full text
Government Document Online Book -
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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, 2006Subjects: Get full text
Government Document Online Book -
14
User fees and refunds for premarket notification submissions (510(k)s)
Subjects: Get full text
Government Document Online Book -
15
Oversight and business practices of durable medical equipment companies : hearing before the Subcommittee on Financial and Contracting Oversight of the Committee on Homeland Securi...
Subjects: “…Medical instruments and apparatus industry United States.…”
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Government Document Online Book -
16
Guidance for industry, FDA staff, and FDA-accredited third parties.
Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Government Document Online Book -
17
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, 2000Subjects: “…Medical instruments and apparatus Government policy United States.…”
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Government Document Online Book -
18
Medicare issues for manufacturer-level competitive bidding for durable medical equipment /
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Government Document Online Book -
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