Regulatory hurdles in bringing an in vitro diagnostic device to market

被引:0
作者
Smith, KM
Kates, JA
机构
关键词
D O I
暂无
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US, A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.
引用
收藏
页码:1556 / 1557
页数:2
相关论文
共 50 条
[41]   International reference materials - in vitro diagnostic device reagents [J].
WHO EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION, SIXTY-SECOND REPORT, 2013, 979 :30-40
[42]   International reference materials - in vitro diagnostic device reagents [J].
WHO EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION: SIXTY-FOURTH REPORT, 2014, 987 :37-49
[43]   Regulatory Hurdles Anticipated for Horticultural Transgenic Innovations [J].
Koch, M. .
II GENETICALLY MODIFIED ORGANISMS IN HORTICULTURE SYMPOSIUM, 2013, 974 :31-36
[44]   Bacteriophage Therapy: Clinical Trials and Regulatory Hurdles [J].
Furfaro, Lucy L. ;
Payne, Matthew S. ;
Chang, Barbara J. .
FRONTIERS IN CELLULAR AND INFECTION MICROBIOLOGY, 2018, 8
[45]   Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues [J].
Sanders, ME ;
't Veld, JHI .
ANTONIE VAN LEEUWENHOEK INTERNATIONAL JOURNAL OF GENERAL AND MOLECULAR MICROBIOLOGY, 1999, 76 (1-4) :293-315
[46]   Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues [J].
Mary Ellen Sanders ;
Jos Huis in't Veld .
Antonie van Leeuwenhoek, 1999, 76 :293-315
[47]   Technical Problems, Regulatory and Market Challenges in Bringing Herbal Drug into Mainstream of Modern Medicinal Practices [J].
Prabhakar, P. ;
Mamoni, Banerjee .
RESEARCH JOURNAL OF BIOTECHNOLOGY, 2021, 16 (03) :212-222
[48]   Bringing cultured meat to market: Technical, socio-political, and regulatory challenges in cellular agriculture [J].
Stephens, Neil ;
Di Silvio, Lucy ;
Dunsford, Illtud ;
Ellis, Marianne ;
Glencross, Abigail ;
Sexton, Alexandra .
TRENDS IN FOOD SCIENCE & TECHNOLOGY, 2018, 78 :155-166
[49]   A comparison of in vitro cytotoxicity assays in medical device regulatory studies [J].
Liu, Xuemei ;
Rodeheaver, Denise P. ;
White, Jeffrey C. ;
Wright, Ann M. ;
Walker, Lisa M. ;
Zhang, Fan ;
Shannon, Stephen .
REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2018, 97 :24-32
[50]   DRUG-DEVICE COMBINATION PRODUCTS: REGULATORY LANDSCAPE AND MARKET GROWTH [J].
Bayarri, L. .
DRUGS OF TODAY, 2015, 51 (08) :505-513