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 development 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.

Anesthesia and Critical Care 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 anesthesia and critical care devices.

MCRA is a world-class provider of regulatory strategy and advice for anesthesia and critical care devices, including:

  • Abnormal Breathing Sound Devices

  • Airway Monitoring Systems

  • Algesimeters

  • Anesthesia catheters, filters, and needles

  • Anesthesia gas and oxygen masks

  • Anesthesia gas machines and vaporizers

  • Anesthesia pain monitors

  • Apnea monitors

  • Breathing Frequency Monitor

  • Breathing Gases Mixer

  • Carbon dioxide absorber and anesthetic gas scavengers

  • CPAP and BiPAP devices

  • Cricothyrotomy devices

  • Dental Protectors

  • Depth of anesthesia monitors

  • Endotracheal, endobronchial, and tracheostomy tubes and stylets

  • End-tidal CO2 monitors and masks

  • Epidural catheters, needles, and delivery devices

  • Gas Analyzers

  • High flow oxygen delivery devices

  • Humidifier and masks

  • Hyperbaric chambers

  • Infant baby monitors

  • Laryngoscopes

  • Nebulizers

  • Nerve stimulators

  • Nitric oxide delivery and generating devices

  • Opioid use disorder devices

  • Oral and nasal airways

  • Oxygen concentrators

  • Oxygen conservers

  • Oxygen tents

  • Peripheral nerve blocks

  • Portable air compressor

  • Pulmonary function calculators

  • Pulse oximeters

  • Spirometers

  • Topical Anesthesia Applicator

  • Tracheobronchial suction catheters

  • Ultrasound guided nerve blocks

  • Ventilators

  • Ventilatory Effort Recorder

US Regulatory Services

MCRA has industry leading specialization in the full spectrum of anesthesia and critical care medical devices, with strong regulatory and scientific leadership offering deep expertise in the complex anesthesia and critical care 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

Contact an anesthesia and critical care us regulatory Expert

Services in Anesthesia and Critical Care Devices

Anesthesia Quality Assurance

Anesthesia Reimbursement

Anesthesia CRO

Anesthesia Global Regulatory