Sinai BioDesign Hosts FDA Representative to Discuss Medical Device Submissions

Sinai BioDesign, an organization of the Icahn School of Medicine at Mount Sinai focused on the development of biomedical technologies, hosted U.S. Food and Drug Administration (FDA) representative Joshua Chetta on October 1 to discuss the regulations and requirements for device submission and review. Chetta offered an overview on Investigational Device Exemptions (IDEs) and Q-Submissions, two of the many forms of reviewal regulated by the FDA for research discoveries.

As a member of the Policy and Operations Team in the Office of Clinical Evidence and Analysis, Chetta shared the main goal of the FDA’s processes: to make sure patients have access to high quality, safe medical devices.

“Engaging talks like Dr. Chetta’s can remove the fear around collaborating with regulatory agencies, which can help Mount Sinai researchers expedite their technologies to the patient community,” said Turner Baker, Clinical Research Fellow and member of Sinai BioDesign who organized the event.

Attendees discovered the function of the Q-Submission, which provides early feedback on potential or planned regulatory submissions. The most common type of Q-Submission is a Pre-Submission, or Pre-Sub, a recommended procedure that will kickstart the conversation and introduce the technology to the FDA review team. IDEs are clinical investigations of devices using feasibility and pivotal studies for assessment.

“As major medical institutions like Mount Sinai are increasingly focused on innovation and entrepreneurship, it’s vitally important that we have an open dialogue and early engagement with the FDA to guide our R&D efforts,” said Anthony Costa, PhD, Director, Sinai BioDesign.

Chetta also shared helpful tips for a seamless IDE submission process and ways to increase the likelihood of review team acceptance. A key step is to provide organized, complete documents that create a narrative of the study, explaining how and why the data was collected. He also encouraged the use of the Pre-Sub, a helpful resource in getting started.

“It’s never too early to start talking to us,” said Chetta. “We are a group of enthusiastic scientists and engineers who really enjoy the part of the job where we can discuss cool, new devices.”

Learn more about Sinai BioDesign and access the FDA’s medical device submission guidelines for further details.