FDA Regulatory and Clinical Services for the Medical Technology Industry

Experience

The M Squared Associates team has experience with devices reviewed by every Office within FDA Center for Devices and Radiological Health (CDRH) Office of Device Evaluation (ODE), by the Office of In Vitro Diagnostics and Radiological Health (OIR), and by the Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).

Office of Health Technology 1 (OHT 1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices)

Division of Health Technology 1 A (Ophthalmic Device)

Division of Health Technology 1 B (Dental Devices)

Division of Health Technology 1 C (Anesthesia, Respiratory, and ENT Devices)

Office of Health Technology 2 (OHT 2: Cardiovascular Devices)

Division of Health Technology 2 A (Cardiac Electrophysiology, Diagnostics, and Monitoring Devices)

Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices)

Division of Health Technology 2 C (Coronary and Peripheral Intervention Devices)

Office of Health Technology 3 (OHT 3: Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors)

Division of Health Technology 3 A (Gastroenterology, Renal, Endoscopy, Transplant and Obesity Devices)

Division of Health Technology 3 B (Reproductive and Urology Devices)

Division of Health Technology 3 C (Drug Delivery and General Hospital Devices and Human Factors)

Office of Health Technology 4 (OHT 4: Surgical and Infection Control Devices)

Division of Health Technology 4 A (General Surgery Devices)

Division of Health Technology 4 B (Infection Control and Plastic and Reconstructive Surgery)

Office of Health Technology 5 (OHT 5: Neurological and Physical Medicine Devices)

Division of Health Technology 5 A (Neurosurgical, Neurointerventional and Neurodiagnostics)

Division of Health Technology 5 B (Neuromodulation and Rehabilitation Devices)

Office of Health Technology 6 (OHT 6: Orthopedic Devices)

Division of Health Technology 6 A (Joint Arthroplasty Devices)

Division of Health Technology 6 B (Spinal Devices)

Division of Health Technology 6 C (Restorative, Repair and Trauma Devices)

Office of Health Technology 7 (OHT 7: In Vitro Diagnostics and Radiological Health - OIR)

Division of Chemistry and Toxicology Devices

Division of Immunology and Hematology Devices

Division of Molecular Genetics and Pathology

Division of Microbiology Devices

Division of Radiological Health

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

Office of Cellular, Tissue and Gene Therapies