Orchid Design Selected to Participate in FDA’s Submission Tracker Pilot Program

FDA selected Orchid Design to be the sole regulatory consulting firm to participate in its 510(k) submission tracking initiative. The web-based program will track status and key details of 510(k) submissions to support transparency and eliminate confusion that often surrounds the FDA Review Clock.

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, comments, “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.”

Orchid Design will be working alongside two of the largest medical device manufacturers to collaborate with the FDA on this project.

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