Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
“General Information Concerning Patents”. US Patent and Trademark Office. www.uspto.gov/go/pac/doc/general/
“Rapid Lateral Flow Test Strips: Considerations for Product Development”. Millipore Inc., 2006.
“Mandatory Guidelines and Proposed Revisions to Mandatory Guidelines for Federal Workplace Drug Testing Programs; Notices”. Federal Register, Vol. 69, No. 71 pp. 19644–19673.
“Procedures for Specimen Collection and the Detection and Quantitation of Drugs of Abuse in Urine”, by Australian/New Zealand Standard. AS/NZS 4308:2008, March 19, 2008.
“Design Control Guidance For Medical Device Manufacturers”. FDA Center for Devices and Radiological Health, March 11, 1997, www.fda.gov/cdrh/comp/designgd.pdf
“Basic Facts about Trademarks”. US Patents and Trademark Office. www.uspto.gov/web/offices/tac/doc/basic
“Getting to Market with a Medical Device” US Food and Drug Administration. www.fda.gov/CDRH/DEVADVICE/3122
Smith, K. and Kates, J. (1966) Regulatory hurdles in bringing an in vitro diagnostic device to market. Clin. Chem. 42(9):1556–1557.
“CLIA – Clinical Laboratory Improvement Amendments”. US Food and Drug Administration. www.fda.gov/CDRH/clia/
“Public Health Service; CLIA Program; Categorization of Waived Test”. Department of Health and Human Services, Health Care Financing Administration, Federal Register 42 CFR 493.15 (b) and 42 CFR 493.15 (c), September 13, 1995, Vol. 60, No. 177, pp. 47534–47543.
“Guidance Notes on In Vitro Diagnostic Medical Devices Directive 98/79/EC”. Competent Authority (UK), February 2006, www.mhra.gov.uk/Howweregulate/Devices/InVitroDiagnosticMedical DevicesDirective/index.htm
“Food and Drug Administration, Title 21, Part 820 Quality System Regulation”. 21CFR820.100
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2009 Humana Press, a part of Springer Science+Business Media, LLC
About this chapter
Cite this chapter
Wong, R.C. (2009). Regulatory Issues in the Development and Marketing of Lateral Flow Immunoassays. In: Wong, R., Tse, H. (eds) Lateral Flow Immunoassay. Humana Press. https://doi.org/10.1007/978-1-59745-240-3_11
Download citation
DOI: https://doi.org/10.1007/978-1-59745-240-3_11
Published:
Publisher Name: Humana Press
Print ISBN: 978-1-58829-908-6
Online ISBN: 978-1-59745-240-3
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)