Regulatory hurdles in bringing an in vitro diagnostic device to market

被引：0

作者：

Smith, KM

Kates, JA

机构：

来源：

CLINICAL CHEMISTRY | 1996年 / 42卷 / 09期

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

页码：1556 / 1557

页数：2

共 50 条

[31] Bringing a drug to market
Martin, D
[J]. VETERINARY TECHNICIAN, 2004, 25 (01): : 38 - 40
[32] Bringing the market back in
Friedman, J
[J]. CRITICAL REVIEW, 1997, 11 (03) : 407 - 467
[33] Bringing PCI to market
Cleveland, Rory
[J]. PCI JOURNAL, 2011, : 144 - 144
[34] BRINGING THE MARKET TO LIBRARIES
LEWIS, DW
[J]. JOURNAL OF ACADEMIC LIBRARIANSHIP, 1984, 10 (02) : 73 - 76
[35] NONINVASIVE PRENATAL DIAGNOSTIC TECHNOLOGY - MEDICAL, MARKET, OR REGULATORY MODEL
ANNAS, GJ
[J]. FETAL CELLS IN MATERNAL BLOOD: PROSPECTS FOR NONINVASIVE PRENATAL DIAGNOSIS, 1994, 731 : 262 - 268
[36] Malignant Mesothelioma: Overcoming Diagnostic Hurdles
Dharshini, R. Priya
Priyadarshini, Sarah Grace
Jayaganesh, P.
[J]. CUREUS JOURNAL OF MEDICAL SCIENCE, 2024, 16 (09)
[37] Bringing Smart Pills to Market: FDA Regulation of Ingestible Drug/Device Combination Products
Avery, Matthew
Liu, Dan
[J]. FOOD AND DRUG LAW JOURNAL, 2011, 66 (03) : 329 - 352
[38] ASSESSMENT OF IN VITRO DIAGNOSTIC REIMBURSEMENT PRACTICES IN EUROPEAN COUNTRIES: IDENTIFIED HURDLES AND POSSIBLE SOLUTIONS.
Govaerts, L.
Simoens, S.
van Dyck, W.
Huys, I
[J]. VALUE IN HEALTH, 2018, 21 : S270 - S270
[39] International reference materials - in vitro diagnostic device reagents
[J]. WHO EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION: SIXTY-THIRD REPORT, 2014, 980 : 35 - 35
[40] International reference materials - In vitro diagnostic device reagents
[J]. WHO EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION: SIXTY-SIXTH REPORT, 2016, 999 : 57 - 76

← 1 2 3 4 5 →