MCRA’s leading experts are specialized in achieving success with the US FDA. Our team has industry leading experience with global regulatory strategy and deep understanding of the device lifecycle assisting through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization, providing MCRA's clients with the best representation to the US FDA in demonstrating the science, safety, and efficacy of their technologies.
Contact an ivd device US Regulatory Expert
IVD Device Experience
MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class medical devices.
MCRA is a world-class provider of regulatory strategy and advice for IVD devices, including:
- Anemia in vitro diagnostics
- Antimicrobial resistance marker genetic in vitro diagnostics
- Antimicrobial susceptibility (AST) in vitro diagnostics
- Autoimmune disorder in vitro diagnostics
- Bacterial infection in vitro diagnostics
- Blood clotting disorder in vitro diagnostics
- Breath in vitro diagnostics
- Cancer in vitro diagnostics
- Cancer monitoring in vitro diagnostics
- Cancer Predisposition Risk Assessment in vitro diagnostics
- Cardiovascular disease in vitro diagnostics
- Chemistry analyte in vitro diagnostics
- Companion Diagnostic (CDx) in vitro diagnostics
- Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection in vitro diagnostics
- Diabetes in vitro diagnostics
- Digital Pathology in vitro diagnostics
- Drugs of abuse in vitro diagnostics
- Fever-causing infection in vitro diagnostics
- Food and other allergy in vitro diagnostics
- Fungal infection in vitro diagnostics
- Gastrointestinal bleeding in vitro diagnostics
- Gastrointestinal pathogens in vitro diagnostics
- Gene expression profiling in vitro diagnostics
- Gene expression profiling test system in vitro diagnostics
- Genetic health risk (GHR) in vitro diagnostics
- Heavy metal in vitro diagnostics
- Immune deficiency in vitro diagnostics
- Immunoglobulin light chain amyloidosis in vitro diagnostics
- Immunohistochemistry (IHC) in vitro diagnostics
- In vitro diagnostic instrumentation
- In vitro diagnostics supported by over the counter (OTC), point of care (POC), or CLIA waiver studies
- Infectious disease in vitro diagnostics
- Latent viral infection in vitro diagnostics
- Liquid biopsy in vitro diagnostics
- Medical Countermeasure in vitro diagnostics
- Minimal Residual Disease (MRD)/tumor burden in vitro diagnostics
- Neural tube defects in vitro diagnostics
- Next generation sequencing based tumor mutation profiling in vitro diagnostics
- Organ damage/disfunction in vitro diagnostics
- Pharmacogenetic/Pharmacogenomic in vitro diagnostics
- Postnatal chromosomal copy number variation detection in vitro diagnostics
- Primary hemostatic function in vitro diagnostics
- Respiratory pathogens in vitro diagnostics
- Semen analysis in vitro diagnostics
- Sepsis and septic shock prognosis in vitro diagnostics
- Sexually transmitted disease in vitro diagnostics
- Specimen collection devices
- Therapeutic Drug Monitoring (TDM) in vitro diagnostics
- Traumatic brain injury (TBI) in vitro diagnostics
- Viral infection in vitro diagnostics
- Women’s health in vitro diagnostics
US Regulatory Services
MCRA has industry leading specialization in the full spectrum of IVD devices, with strong regulatory and scientific leadership offering deep expertise in the complex IVD device space.
Our comprehensive regulatory services include:
- Global and US regulatory strategy
- Regulatory landscape assessment
- Gap analysis
- Investigational Device Exemption (IDE)
- De Novo
- 510(k)
- Premarket Approval (PMA)
- FDA appeals
- FDA training
- FDA warning letters and 483 observations
- Pre-clinical testing plan
- Clinical testing plan
- Due diligence services
- Agency interaction
- Device classification
- Import/export
- Labeling
- FDA meeting strategy
- Real-time reviews
- Device listing
- Establishment registration
- Regulatory file letters
- Medical device reporting
- IDE Reporting