FDA perspectives on potential microarray-based clinical diagnostics.
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.
Tezak
Zivana
Z
Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD 20850, USA. zivana.tezak@fda.hhhs.gov
Ranamukhaarachchi
Daya
D
Russek-Cohen
Estelle
E
Gutman
Steven I
SI
D004247:DNA / Q000235:genetics; D005826:Genetics, Medical / Q000592:standards*; D005838:Genotype; D006801:Humans; D020411:Oligonucleotide Array Sequence Analysis / Q000592:standards*; D020641:Polymorphism, Single Nucleotide; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
D004247:DNA