The FDA review process: Obtaining premarket approval for the PAPNET testing system

被引:0
|
作者
Mango, LJ
机构
关键词
cervical smears; image analysis; computer-assisted; mass screening; laboratory diagnosis;
D O I
暂无
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
引用
收藏
页码:138 / 140
页数:3
相关论文
共 50 条
  • [1] Review of the FDA Premarket Approval Studies Comparing SMILE and LASIK Reply
    Schallhorn, Julie
    Schallhorn, Steven
    JOURNAL OF REFRACTIVE SURGERY, 2020, 36 (02) : 131 - 132
  • [2] FDA: Gene Tests Need Premarket Approval
    Kuehn, Bridget M.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (02): : 145 - 145
  • [3] SMILE: Results of FDA Premarket Approval Clinical Trial
    Bitzer, Michaela
    KLINISCHE MONATSBLATTER FUR AUGENHEILKUNDE, 2020, 237 (12) : 1386 - 1387
  • [4] Evidence Strength in FDA Premarket Approval of Cardiovascular Devices
    Kong, David F.
    Hasselblad, Vic
    Krucoff, Mitchell W.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 303 (16): : 1599 - 1600
  • [5] US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement
    Alam, Murad
    Shi, Victoria J.
    Maisel-Campbell, Amanda
    Cressey, Brienne D.
    Nadir, Umer
    Koza, Eric
    Haq, Misha
    Ahmed, Areeba
    Ma, Melissa S.
    Weil, Alexandra
    Cahn, Brian A.
    Lee, Angela Y.
    Shapiro, Sidney
    Poon, Emily
    JAMA NETWORK OPEN, 2024, 7 (10)
  • [6] The Quality of Study Evidence Examined By the FDA In Premarket Approval Of Stents
    Dhruva, Sanket S.
    Bero, Lisa A.
    Redberg, Rita F.
    AMERICAN JOURNAL OF CARDIOLOGY, 2009, 104 (6A): : 38D - 38D
  • [7] Gender Bias in Studies for FDA Premarket Approval of Cardiovascular Devices
    Dhruva S.S.
    Cullen E.B.
    Redberg R.F.
    Current Cardiovascular Risk Reports, 2014, 8 (7) : 1 - 5
  • [8] Evidence Strength in FDA Premarket Approval of Cardiovascular Devices Reply
    Redberg, Rita F.
    Dhruva, Sanket S.
    Bero, Lisa A.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 303 (16): : 1600 - 1601
  • [9] Sustain™ dental implant FDA premarket approval clinical trial
    Olin, PS
    Swift, JQ
    JOURNAL OF DENTAL RESEARCH, 1998, 77 : 711 - 711
  • [10] Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices
    Dhruva, Sanket S.
    Bero, Lisa A.
    Redberg, Rita F.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2009, 302 (24): : 2679 - 2685