In Vitro Diagnostics

In 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 Tests

Spotlight

• In Vitro Diagnostic Product Database
• Search the CLIA Database
• IVD Over the Counter (OTC) Database
• Currently Waived Analytes

Recalls & Alerts

• In Vitro Diagnostic Device Recalls Database

Approvals & 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 Search

Authorizations (EUA)

• Emergency Use Authorizations

Contact 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