Companion Diagnostic tests are regulated devices. Careful oversight to ensure compliance with Federal Regulations and development according to agency guidelines is required for a successful marketing application
Our regulatory and quality teams are an integral part of all CDx projects. Regulatory works closely with our scientists and medical teams to ensure that assays are sufficiently analytically validated for their intended use. Additionally, the NeoGenomics Regulatory Affairs group can support the following submissions and interactions with the Food and Drug Administration.
- Risk assessments
- Pre-submission meetings with CDRH
- IDE filings
- PMA filings
- HUD and HDE filings
NeoGenomics has successfully completed four FDA audits at our Fort Myers and Aliso Viejo facilities with no FDA form 483’s.
Our laboratory licenses and accreditations can be found here.
- Personalized Medicine Coalition
- List of FDA-approved Companion Diagnostics
- FDA – Companion Diagnostics Overview
- FDA – Precision Medicine Overview
- Guidance for Industry – In Vitro Companion Diagnostics
- Guidance for Industry - Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
- Guidance for Industry - Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
- CDRH Breatkthrough Devices Program
- Guidance for Industry – Humanitarian Use Devices
- Clinical Laboratory Standards Institute