Why Neogenomics?
We provide in-house regulatory and compliance teams and have enjoyed a 100% success rate with institutional review board (IRB) and US Food and Drug Administration (FDA) submissions, often receiving consistent, favorable FDA feedback.
We’ve got you covered
Our regulatory and quality teams work closely with our scientific 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 FDA:
- Risk assessments
- Pre-submission meetings with the Center for Devices and Radiological Health (CDRH)
- Investigational Device Exemption (IDE) filings
- Premarket approval (PMA) filings
- Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) filings
Our accreditations
- Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists
(CAP) basic standard certification - Certified in International Organization for Standardization (ISO) 13485 — quality management system
- ISO 15189
- 21 Code of Federal Regulations (CFR) Part 820
- 21 CFR Part 11 LIMS system
Compliance
NeoGenomics believes that no commercial objective is more important than compliance with all applicable laws, rules, and regulations. We are committed to compliance with all laws, rules, and regulations governing our business, and we strictly adhere to all internal policies and procedures, including the Health Insurance Portability and Accountability Act (HIPAA), Occupational Safety and Health Administration (OSHA), CAP, and others. To ensure this compliance, NeoGenomics has developed compliance and HIPAA privacy programs that follow US government guidelines.
Project requirements
- Type of project (i.e., biomarker discovery, translational research, assay design and development, clinical trial testing, FDA filing, launch preparation, commercialization)
- Test modality of interest (i.e., anatomic pathology, molecular, multiplexed immunofluorescence, flow cytometry, fluorescence in situ hybridization [FISH], and cytogenetics)
- Target timeline
- Quality and regulatory requirement
Specimen requirements and guidelines
Licenses & certifications
Our laboratory licenses can be found on our Client support & resources page.