Orchid Design has been selected by the FDA to be the sole regulatory consulting firm to participate in their submission tracking initiative. The FDA is piloting a web-based program to track the status and key details of 510(k) submissions in an effort to add transparency and eliminate confusion surrounding the often misunderstood “FDA Review Clock.”
Kellen Hills, senior quality and regulatory consultant for Orchid Design commented in the August 06, 2015 news release, “The insights gained from working directly with the FDA on this project will allow us to efficiently and effectively navigate the regulatory submission process, as well as bring important issues to the FDA’s attention from a perspective they may otherwise not have considered in the development of the Submission Tracker program.”
A representative from Orchid Design told OTW, “Orchid Design responded to FDA’s request for participants by sharing our regulatory team’s prior experiences with other global regulators submission tracking processes. We also work with multiple branches within FDA and are not restricted to a single device type. Orchid Orthopedics is also a key contract manufacturer to many of the major OEMs [original equipment manufacturer], so the relationship between FDA/OEM/Contract Manufacturer is already established.”
“We bring a unique perspective, in that we work with various size OEM’s, from single physicians to small startups, to midsize OEMs to multi-billion dollar global companies. The size of the organization brings unique challenges when working with FDA, from a resource standpoint, from a knowledge standpoint, and from an expectation standpoint. We also work with multiple branches within FDA and are not restricted to a single device type (from large joint orthopedics, to spine, to dental, to neuro, to endoscopy, to urology, etc.).”
“Many smaller companies still feel that the entire 510(k) submission process is a ‘black box;’ you send something to FDA and hope to hear back in 90 days. The FDA has put out guidance documents to help explain the review clock, but there is still uncertainty when trying to determine exactly where in the review process you are, when the clock starts and stops, and when you should expect feedback.”
