MCRA RESOURCE CENTER
REGULATORY Because the spinal sector is so dynamic, guidance as well as MCRA’s assistance can generate a dominant market presence either by establishing a client’s spinal device portfolio or setting the barrier to market entry for their competition.
SPINE
• Guidance Document for the Preparation of IDEs for Spinal Systems • Guidance Document: Spinal System 510(k)s - Guidance for Industry and FDA Staff • Guidance Document: Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff • Points fo Consider in the Preparation of IDEs for Total Artificial Discs • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
