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Medical devices and the public's health : the FDA 510(k) clearance process at 35 years

Medical devices and the public's health : the FDA 510(k) clearance process at 35 years
Paper図書
Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.The National Academies Press[2011]<M361-B448>
National Diet LibraryOther Libraries in Japan

Reprocessing of single-use medical devices : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixth Congress, second session ... June 27, 2000 (S. hrg. ; 106-656)

Reprocessing of single-use medical devices : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixth Congress, second session ... June 27, 2000 (S. hrg. ; 106-656)
Microform図書
2000<YCA-Y 4.L 11/4:S.HRG.106-656>
National Diet Library
  • Subject Heading... United States Medical instruments and apparatus -- Safety regulations -- United States

Medical Device User Fee and Modernization Act of 2002 : report (to accompany H.R. 3580) (Report)

Medical Device User Fee and Modernization Act of 2002 : report (to accompany H.R. 3580) (Report)
Microform図書
2002<YCA-Y 1.1/8:107-728>
National Diet Library
  • Subject Heading... United States Medical instruments and apparatus -- Safety regulations -- United States User charges -- United States

Reinventing the regulation of cancer drugs : accelerating approval and expanding access / President Bill Clinton, Vice President Al Gore

Reinventing the regulation of cancer drugs : accelerating approval and expanding access / President Bill Clinton, Vice President Al Gore
Microform図書
1996<YCA-PRVP 42.2:D 84/3>
National Diet Library
  • Subject Heading... United States Medical instruments and apparatus -- Safety regulations -- United States

Medical devices [microform] : FDA can improve oversight of tracking and recall systems : report to the Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives / United States General Accounting Office

Medical devices [microform] : FDA can improve oversight of tracking and recall systems : report to the Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives / United States General Accounting Office
Microform図書
1998<YCA-GA 1.13:HEHS-98-211>
National Diet Library
  • Subject Heading...Administration Medical instruments and apparatus -- Safety regulations -- United States Medical instruments and appar...

Medical device reporting [microform] : improvements needed in FDA's system for monitoring problems with approved devices : report to congressional committees / United States General Accounting Office

Medical device reporting [microform] : improvements needed in FDA's system for monitoring problems with approved devices : report to congressional committees / United States General Accounting Office
Microform図書
1997<YCA-GA 1.13:HEHS-97-21>
National Diet Library
  • Subject Heading...Administration Medical instruments and apparatus -- Safety regulations -- United States Medical instruments and appar...

Reinventing regulation of drugs and medical devices / President Bill Clinton, Vice President Al Gore

Reinventing regulation of drugs and medical devices / President Bill Clinton, Vice President Al Gore
Microform図書
1995<YCA-PRVP 42.2:D 84>
National Diet Library
  • Subject Heading... United States Medical instruments and apparatus -- Safety regulations -- United States

Food and Drug enforcement standards for medical devices : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, September 14, 1995

Food and Drug enforcement standards for medical devices : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, September 14, 1995
Microform図書
1997<YCA-Y 4.G 74/7:F 73/20>
National Diet Library
  • Subject Heading...Administration Medical instruments and apparatus -- Safety regulations -- United States Medical technology -- Governm...

Medical devices : hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, second session, on examining proposed legislation to revise and strengthen the Food and Drug Administration's regulation of medical devices, July 25, 1990 (S. hrg. ; 101-1162)

Medical devices : hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, second session, on examining proposed legislation to revise and strengthen the Food and Drug Administration's regulation of medical devices, July 25, 1990 (S. hrg. ; 101-1162)
Microform図書
1991<YCA-Y 4.L 11/4:S.hrg.101-1162>
National Diet Library
  • Subject Heading...Administration Medical instruments and apparatus -- Safety regulations -- United States

Guidance for medical gloves [microform] : a workshop manual / prepared by Office of Health and Industry Programs, Division of Small Manufacturers Assistance Rev. Sept. 1996 (Medical devices) (HHS publication ; FDA 96-4257)

Guidance for medical gloves [microform] : a workshop manual / prepared by Office of Health and Industry Programs, Division of Small Manufacturers Assistance Rev. Sept. 1996 (Medical devices) (HHS publication ; FDA 96-4257)
Microform図書
1996<YCA-HE 20.4608:M 46/5/996>
National Diet Library
  • Subject Heading..., manuals, etc Medical instruments and apparatus -- Safety regulations -- United States -- Handbooks, manuals, etc

Medical Device User Fee Act of 1994 : report together with dissenting and additional views (to accompany H.R. 4864) (including cost estimate of the Congressional Budget Office) (Report)

Medical Device User Fee Act of 1994 : report together with dissenting and additional views (to accompany H.R. 4864) (including cost estimate of the Congressional Budget Office) (Report)
Microform図書
1994<YCA-Y 1.1/8:103-751>
National Diet Library
  • Subject Heading... United States Medical instruments and apparatus -- Safety regulations -- United States User charges -- United States

Safe Medical Devices Act of 1990 : report (to accompany H.R. 3095) (including cost estimate of the Congressional Budget Office) (Report)

Safe Medical Devices Act of 1990 : report (to accompany H.R. 3095) (including cost estimate of the Congressional Budget Office) (Report)
Microform図書
1990<YCA-Y 1.1/8:101-808>
National Diet Library
  • Subject HeadingMedical instruments and apparatus -- Safety regulations -- United States Medical technology -- United ...

Premarket notification, 510(k) : regulatory requirements for medical devices / prepared by Division of Small Manufacturers Assistance, Office of Training and Assistance (HHS publication ; (FDA) 86-4158)

Premarket notification, 510(k) : regulatory requirements for medical devices / prepared by Division of Small Manufacturers Assistance, Office of Training and Assistance (HHS publication ; (FDA) 86-4158)
Microform図書
1986<YCA-HE 20.4606:P 91/986>
National Diet Library
  • Subject HeadingMedical instruments and apparatus -- Safety regulations -- United States

Medical device regulation [microform] : too early to assess European system's value as model for FDA : report to the Chairman, Committee on Labor and Human Resources, U.S. Senate / United States General Accounting Office

Medical device regulation [microform] : too early to assess European system's value as model for FDA : report to the Chairman, Committee on Labor and Human Resources, U.S. Senate / United States General Accounting Office
Microform図書
1996<YCA-GA 1.13:HEHS-96-65>
National Diet Library
  • Subject Heading... -- Evaluation Medical instruments and apparatus -- Safety regulations -- United States Medical instruments and appar...

FDA's drug and device review process : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, February 6, 1992

FDA's drug and device review process : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, February 6, 1992
Microform図書
1992<YCA-Y 4.En 2/3:102-132>
National Diet Library
  • Subject Heading...ic scleroderma Medical instruments and apparatus -- Safety regulations -- United States Drugs -- Testing -- Law and l...

Medical device safety : hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, on H.R. 3095 ... November 6, 1989 and July 17, 1990

Medical device safety : hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, on H.R. 3095 ... November 6, 1989 and July 17, 1990
Microform図書
1990<YCA-Y 4.En 2/3:101-157>
National Diet Library
  • Subject HeadingMedical instruments and apparatus -- Safety regulations -- United States Surgical instruments and appa...

Regulatory requirements for medical devices : a workshop manual / prepared by the Division of Small Manufacturers Assistance, Office of Training and Assistance 3rd ed (HHS publication ; FDA 85-4165)

Regulatory requirements for medical devices : a workshop manual / prepared by the Division of Small Manufacturers Assistance, Office of Training and Assistance 3rd ed (HHS publication ; FDA 85-4165)
Microform図書
1985<YCA-HE 20.4606:M 46/985>
National Diet Library
  • Subject HeadingMedical instruments and apparatus -- Safety regulations -- United States

An overview of the medical device reporting regulation : final rule, effective December 13, 1984, 21 CFR part 803 (DHHS publication ; no. (FDA) 85-4194)

An overview of the medical device reporting regulation : final rule, effective December 13, 1984, 21 CFR part 803 (DHHS publication ; no. (FDA) 85-4194)
Microform図書
1984<YCA-HE 20.4606:M 46/3>
National Diet Library
  • Subject HeadingMedical instruments and apparatus -- Safety regulations -- United States

Premarket notification, 510(k) : regulatory requirements for medical devices / prepared by Division of Small Manufacturers Assistance, Office of Training and Assistance (HHS publication ; FDA 83-4158)

Premarket notification, 510(k) : regulatory requirements for medical devices / prepared by Division of Small Manufacturers Assistance, Office of Training and Assistance (HHS publication ; FDA 83-4158)
Microform図書
1984<YCA-HE 20.4606:P 91>
National Diet Library
  • Subject HeadingMedical instruments and apparatus -- Safety regulations -- United States

FDA and the medical device industry : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, March 25 and June 3, 1992

FDA and the medical device industry : hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, second session, March 25 and June 3, 1992
Microform図書
1992<YCA-Y 4.En 2/3:102-129>
National Diet Library
  • Subject Heading...rupt practices Medical instruments and apparatus -- Safety regulations -- United States
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