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Direct-to-Consumer Tests | FDA

    https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests
    1. FDA Safety Communication: The FDA Warns Against the use of Many Gene…2. Press Announcement: FDA Allows Marketing of First Direct-to-Consume…3. Press Anno… See more

Regulation of Genetic Tests - Genome.gov

    https://www.genome.gov/about-genomics/policy-issues/Regulation-of-Genetic-Tests
    FDA initially applied enforcement discretion on LDTs T because clinical genetic testing was not very widespread in the past - however, due to the rapid …

What is Gene Therapy? | FDA - U.S. Food and Drug …

    https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy
    There are a variety of types of gene therapy products, including: Plasmid DNA: Circular DNA molecules can be genetically engineered to carry therapeutic genes into human …

Table of Pharmacogenetic Associations | FDA

    https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations
    Oct 26, 2022

Genetic Analysis Instruments | Thermo Fisher Scientific

    https://www.thermofisher.com/us/en/home/clinical/diagnostic-testing/instruments-automation/genetic-analysis-instruments.html
    Based on Sanger sequencing, one of the most widely used, widely trusted sequencing methodologies available, the 3500 Dx Genetic Analyzer can be operated in either IVD …

In Vitro Diagnostics | FDA

    https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics
    In Vitro Diagnostics | FDA In Vitro Diagnostics In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human …

Leading innovators in genetic variance analysis for the medical …

    https://www.medicaldevice-network.com/data-insights/innovators-genetic-variance-analysis-medical-devices/
    Leading innovators in genetic variance analysis for the medical devices industry The medical devices industry continues to be a hotbed of innovation, with …

At-home genetic testing: Uses and cautions

    https://www.medicalnewstoday.com/articles/188544
    Genetic testing can help identify which diseases an individual is at risk of. This can make early or preventive treatment possible and it can help people …

Genetic database software as medical devices

    https://onlinelibrary.wiley.com/doi/10.1002/humu.23621
    Physicians, clinical laboratories, and public human genetic variant databases (hereafter “variant databases”) all contribute to an interpretive “supply chain” supporting …

How to Determine if Your Product is a Medical Device | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
    Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. …



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