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In Vitro Diagnostics

                        
                Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters Home
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          In Vitro DiagnosticsProducts and Medical Procedures In Vitro Diagnostics
  	
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    PrintIn vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.

News & Events

Studies Using Leftover, Deidentified Human Specimens Require IRB Review – Letter to Industry
	Good Clinical Practice Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic Device Premarket Submissions
	CDRH’s Approach to Tumor Profiling Next Generation Sequencing Tests (PDF - 177KB)
	Letter to Viracor-IBT Laboratories, Inc. regarding Zika Virus IgG, and Zika Virus IgG and IgM Panel (PDF - 921KB)
	Letter to Medical Diagnostic Laboratories, LLC regarding the Zika Virus–Blood–PCR Test (PDF - 40KB)
	Letter to First Diagnostic Corporation regarding the ATFirst’s One Step Zika Antibody Test (PDF - 691KB)
	Letter to Texas Children’s Hospital and Houston Methodist Hospital regarding the Zika Direct Test (PDF - 558KB)
	Letter to MD Biosciences Regarding the Zika Virus RNA by RT-PCR Assay (PDF - 357KB)
	Letter to SoloPAP concerning the SoloPAP Home HPV&PAP test (PDF - 202KB)
	Letter to Sure Genomics, Inc. concerning SureDNA Test for Collection of Saliva Samples for DNA Sequencing (PDF - 122KB)
	Letter to Healthspek LLC concerning the Healthspek PGT test for genes affecting drug metabolism (PDF - 161KB)
	Letter to Genomic Express, Inc. concerning pharmacogenomic tests (PDF - 185KB)
	Letter to Kailos Genetics, Inc. concerning test to analyze multiples genes (PDF - 176KB)
	Letter to Harmonyx concerning test for antiplatelets, statins, ADHD, and pain (PDF - 174KB)
	Pathway Genomics Letter - September 21, 2015 (PDF - 48KB)
	The CDC and FDA Antimicrobial Resistance Isolate Bank
	Letter to Biosense Technologies Private Limited Concerning the uChek Urine Analyzer
	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 - 114KB)
	Letter to Illumina, Inc. Concerning the Illumina Infinium HumanHap550 array (PDF - 169KB)
	Letter to 23andMe, Inc. Concerning the 23andMe Personal Genome Service (PDF - 163KB)
	Letter to DNA-Cardiocheck, Inc. Concerning the DNA CardioCheck Test (PDF - 167KB)
	Letter to DNA4Life Concerning the Pharmacogenetic Report (PDF - 164KB)
	Letter to Interleukin Genetics, Inc. Concerning the PerioPredict® Genetic Test (PDF - 211KB)OIR Regulatory Resources

FDA eSubmitter
	Overview of IVD Regulation
	Clinical Laboratory Improvement Amendments (CLIA)
	Device Advice: Comprehensive Regulatory Assistance
	In Vitro Diagnostic Device Labeling Requirements
	CDRH Offices: Office of In Vitro Diagnostics
	Manufacturer Certification Programs
	Suggested Analytical Testing Protocol for In Vitro Diagnostic Devices Manufactured with Heparin Contaminated With Oversulfated Chondroitin Sulfate
	Indications for Use Form (PDF - 1.7MB)
	List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
	Recent Scientific Publications
	Nucleic Acid Based TestsSpotlight

In Vitro Diagnostic Product Database
	Search the CLIA Database
	IVD Over the Counter (OTC) Database
	Currently Waived AnalytesRecalls & Alerts

In Vitro Diagnostic Device Recalls DatabaseApprovals & Clearances

Find All FDA-Approved Home and Lab Tests
	Find All In Vitro Diagnostic Products and Decision Summaries Since November 2003
	510(k) Premarket Notification Database SearchAuthorizations (EUA)

Emergency Use AuthorizationsContact FDA

301-796-5450

**CDRH- Office of Health Technology 7: Office of In Vitro Diagnostics**
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993

                                                                                  Content current as of:
      02/23/2023
                  
                   
Regulated Product(s)
		 Medical DevicesIn Vitro Diagnostics                
                          

                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters
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