FDA Regulation of In Vitro Diagnostics
In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.
In addition, FDA regulation and enforcement discretion relating to IVDs developed by clinical laboratories for internal use, key reagents required for developing such tests, instruments needed to analyze IVDs, and sample collection kits used to obtain specimens will be addressed.
Areas Covered in the Session:
- Definition of IVD
- FDA Regulatory Pathways
- QSR/CLIA Compliance
- Product Labeling
Who Will Benefit:
- CEOs
- VPs
- Compliance officers
- Clinical affairs
- Regulatory affairs
- Quality assurance
- R&D
- CROs
- Consultants
- Contractors/subcontractors
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.
Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.