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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance document is intended to facilitate progress in the field of pharmacogenomics and genetics by helping to shorten development and review timelines, facilitate rapid transfer of new technology from the research bench to the clinical diagnostic laboratory, and encourage informed use of pharmacogenomic and genetic diagnostic devices. It provides recommendations to sponsors and FDA reviewers in preparing and reviewing premarket approval applications (PMA) and premarket notification (510(k)) submissions for pharmacogenetic and other human genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). Array-based tests (commonly referred to as microarrays) are a subset of multiplex tests and are included in the scope of this document. The recommendations within this guidance for elements of a genetic test submission apply to pharmacogenetic (e.g., drug-metabolizing enzyme allele tests, single nucleotide polymorphism (SNP) analysis) and other types of genetic tests. Tests of gene expression and tests for non-heritable (somatic) mutations are not specifically addressed, although many of the same principles may apply. In addition, this guidance considers nucleic acid-based analysis only, but the principles may be applied to other matrices (e.g., protein) when the purpose is to provide genetic information.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2006-D-0232.