Medical Devices
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In Vitro Diagnostics
In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
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News & Events
Correspondence related to Duke University Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy for Chemo-naïve Select Stage IIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genome Predictor of Platinum-Resistance to Guide Therapy Letter to Lumigenix Inc Concerning Direct to Consumer Advertising Letter to American International Biotechnology Services Concerning Direct to Consumer Advertising Letter to Precision Quality DNA Concerning Direct to Consumer Advertising Letter to IDENTIGENE Concerning the Identigene STD Test Letter to Manufacturers of Troponin Assays Listed with the FDA Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA Letters to Manufacturers Concerning Genetic Tests Letter to Manufacturers With HbA1c Assays Listed With the FDA Letter to Navigenics Concerning the NaviGenics Health Compass (PDF - 85KB)Letter to Illumina, Inc. Concerning the Illumina Infinium HumanHap550 array (PDF - 88KB)Letter to 23andMe, Inc. Concerning the 23andMe Personal Genome Service (PDF - 103KB)Archived OIVD News Items
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OIVD Regulatory Resources
FDA eSubmitter Overview of IVD Regulation Clinical Laboratory Improvement Amendments (CLIA) OIVD Guidance Device Advice: Comprehensive Regulatory Assistance In Vitro Diagnostic Device Labeling Requirements Office of In Vitro Diagnostic Device Evaluation and Safety Manufacturer Certification Programs Suggested Analytical Testing Protocol for In Vitro Diagnostic Devices Manufactured with Heparin Contaminated With Oversulfated Chondroitin Sulfate Health Hazard Evaluation Form Indications for Use Form In Vitro Companion Diagnostic Devices - Recent Scientific Publications
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Contact FDA
301-796-5450
CDRH-Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993
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