FDA Regulation of In Vitro Diagnostic Tests. FDA Public Meeting on Oversight of Laboratory Developed Tests July 19 – 20, 2010. Katherine Serrano Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health/FDA [email protected]
Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.
“The X urine test is an immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. It is intended for professional use.”
All IVDs must establish adequate:
Labeling (21 CFR 809.10)
510(k) database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Decision Summary contains the information used to support clearance:
PMA Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm