The US Food and Drug Administration (FDA) has accepted InVivo Therapeutics’ proposed humanitarian device exemption (HDE) modular shell submission and review process for its Neuro-spinal scaffold.
The investigational device is being studied in the INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS (American Spinal Injury Association Impairment Scale) A Spinal Cord Injury.
The modular HDE review process is based on a submission of individual sections or “modules” that constitute a complete HDE submission once all have been submitted. This allows the FDA to review each module separately, allowing the applicant to receive timely feedback and potentially resolve any deficiencies earlier in the review process compared to a traditional HDE application. InVivo’s HDE modular shell is comprised of three modules: a preclinical studies module, a manufacturing module, and a clinical data module. Following the submission of each module, the FDA reviews and provides feedback, typically within 90 days. Upon receipt of the final module, the FDA will make a filing decision that, if positive, triggers the HDE 75-day review clock for an approval decision.
“InVivo’s regulatory approach centres on efficiency and swiftness to market,” Mark Perrin, InVivo’s chief executive officer and chairman, says. “We expect to submit and receive acceptance of the preclinical module by the end of this year and plan to submit the manufacturing and clinical modules in 2017.”