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. 2006 Jan;2(4):236-43.
doi: 10.1186/1479-7364-2-4-236.

FDA perspectives on potential microarray-based clinical diagnostics

Zivana Tezak  1 , Daya Ranamukhaarachchi, Estelle Russek-Cohen, Steven I Gutman
Affiliations

FDA perspectives on potential microarray-based clinical diagnostics

Zivana Tezak et al. Hum Genomics. 2006 Jan.

Abstract

The US Food and Drug Administration (FDA) encourages the development of new technologies such as microarrays which may improve and streamline assessments of safety and the effectiveness of medical products for the benefit of public health. The FDA anticipates that these new technologies may offer the potential for more effective approaches to medical treatment and disease prevention and management. This paper discusses issues associated with the translation of nucleic acid microarray-based devices from basic research and target discovery to in vitro clinical diagnostic use, which the Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health foresees will be important for assurance of safety and effectiveness of these types of devices. General technological points, assessment of potential concerns for transitioning microarrays into clinical diagnostic use and approaches for evaluating the performance of these types of devices will be discussed.

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References

    1. Food, Drug, and Cosmetic Act, 21 U.S.C. 321(h); definition of the term 'device' ('an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is [2] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals')
    1. 21 CFR §809.3(a); definition of in vitro diagnostic devices ('In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.') http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm FDA (cited 1st April, 2004)
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    1. FDA/Drug Information Association. 'Co-development of drug, biological and device products', 29th July, 2004, Arlington, VA. 2004. http://www.diahome.org/Content/Events/04040.pdf Accessed 1st September, 2005.

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