New Medical Device 510(k) Preparation

Posted by Bob Duffy on October 17, 2018 in Projects, Regulatory & Standards Compliance Projects

510(k), FDA, Pre-Submission

Challenge

Client needed FDA input on Regulatory pathway for novel wound care device.

Actions

• Researched prior device clearances for likely Regulatory pathway.
• Prepared FDA pre-submission to get FDA’s input on the Regulatory pathway for the new novel device.
• Submitted pre-submission.

Results

Received favorable FDA feedback confirming the Regulatory pathway for Client’s device.