Sean Fenske, Editor-in-Chief09.16.19
The de novo’s regulatory pathway is the third most common method for getting a product through the agency’s device review process, but hardly well understood by most firms. As such, the FDA has given the regulatory route more attention recently to make it more clear for companies seeking to use the option.
Earlier this year, Intellirod Spine announced it had traversed the pathway successfully, enabling the company to bring the industry’s first spinal surgical device to market using the option. Guiding them along the way was MCRA, a clinical research organization and advisory firm with deep industry experience in regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance.
Taking a moment to speak with ODT, Justin Eggleton, VP of Spine Regulatory Affairs at MCRA LLC, explained why the Intellirod Spine story was significant and how it could continue to improve the industry’s understanding of the de novo pathway.
Sean Fenske: Can you te
Earlier this year, Intellirod Spine announced it had traversed the pathway successfully, enabling the company to bring the industry’s first spinal surgical device to market using the option. Guiding them along the way was MCRA, a clinical research organization and advisory firm with deep industry experience in regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance.
Taking a moment to speak with ODT, Justin Eggleton, VP of Spine Regulatory Affairs at MCRA LLC, explained why the Intellirod Spine story was significant and how it could continue to improve the industry’s understanding of the de novo pathway.
Sean Fenske: Can you te
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