08.04.15
Shelton, Conn.-based Orchid Design has been selected by the U.S. Food and Drug Administration (FDA) to be the sole regulatory consulting firm to participate in their submission tracking initiative.
The regulatory watchdog 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.”
“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,” said Kellen Hills, senior quality and regulatory consultant for Orchid Design.
Orchid Design will be working alongside two of the largest medical device manufacturers to collaborate with the FDA on this project.
Orchid Design, a division of Holt, Mich.-based Orchid Orthopedic Solutions, provides design, development and regulatory submission services. The company has two design centers located in Shelton and Memphis, Tenn., focused on the orthopedic medical device market.
Editor's note: For more information on regulatory submissions in orthopedics, check out this recent ODT article authored by Kellen Hills.
The regulatory watchdog 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.”
“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,” said Kellen Hills, senior quality and regulatory consultant for Orchid Design.
Orchid Design will be working alongside two of the largest medical device manufacturers to collaborate with the FDA on this project.
Orchid Design, a division of Holt, Mich.-based Orchid Orthopedic Solutions, provides design, development and regulatory submission services. The company has two design centers located in Shelton and Memphis, Tenn., focused on the orthopedic medical device market.
Editor's note: For more information on regulatory submissions in orthopedics, check out this recent ODT article authored by Kellen Hills.