Contact a Spine Regulatory Expert

Spine 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 spine devices. 

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

•    3D printed devices

•    Annulus repair

•    Atlanto-cervico-thoracic fixation systems

•    Bone void fillers

•    Cervical interbody cages

•    Combination devices

•    Disc nucleus replacement

•    Dura/vertebrae anti-adhesion

•    Hydrocephalic shunt devices

•    Instrument navigation systems

•    Laminoplasty plates

•    Lumbar interbody cages

•    Pain relief

•    Pedicle screw systems

•    Reconstruction of intervertebral disc

•    SI-joint screws

•    Spinal fusion

•    Spine surgery

•    Total disc replacement

•    Vertebral augmentation

•    Vertebral body replacements

US Regulatory Services

MCRA has industry leading specialization in the full spectrum of musculoskeletal medical devices, supporting hundreds of clients seeking regulatory designations, clearances, and registrations with proven track record of six approved spine-device PMAs in the US.

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 a Spine Regulatory Expert