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.

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