Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices Guidance for Industry and Food and Drug Administration Staff June 2015
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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA is issuing this guidance to provide industry and agency staff with recommendations for the suggested format and content of an Abbreviated 510(k) submission for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices and recommendations for addressing certain labeling issues relevant to the review process specific to these devices.
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-2014-D-1242.