FDA partners with nonprofit device incubator Fogarty Institute to improve approval efficiency

The U.S. Food and Drug Administration (FDA) is seeking a better rapport with med tech startups in a new collaboration with the Fogarty Institute for Innovation, one of the more prominent medical device incubators. The pair has developed a new educational program designed to improve collaboration between medical device innovators and the FDA that's expected to make the device approval process more efficient.

The initial FDA participants included representatives from the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health (CDRH). These FDA staff participated in a one-week educational program at the Fogarty Institute so they better understand what's involved in bringing a device to market in the U.S. and what FDA policy and decisions mean for startups.

"Our goal at the FDA is to promote innovation and efficacy in medical devices, to better serve the American public while maintaining the highest level of safety," Dr. Murray Sheldon, associate director for technology and innovation at CDRH, said in a statement. "We believe this collaboration will assist the FDA in better understanding the unique considerations of med tech startups; and the costs, time and money incurred during early-stage development to bring their innovation to doctors and patients."

There has been substantial controversy of late around a provision in the 21st Century Cures Act that would offer faster medical device approvals via a breakthrough pathway, similar to what is already in place for drugs. But unlike with medicines, Europe and other countries around the world typically gain access to novel medical devices before the FDA is able to approve them for the U.S. market.

In addition, the ongoing influx of consumer-oriented health devices and apps creates a whole new layer of complexity for the U.S. regulatory agency as it continues to sort out what it will and won't regulate. Last year, the FDA said it would not regulate hardware or software that presented medical device data without modification or altering typical device functions and parameters.

Fogarty Institute President and CEO Ann Fyfe

On the new collaboration with the FDA, Fogarty Institute President and CEO Ann Fyfe said, "This is a critical step to help develop a safe and effective U.S. medical device ecosystem, with the end goal of supporting medical innovation that benefits patients."

"The Institute provided FDA staff with access to a 'living laboratory' of medical device start-up companies, providing insight into the challenges faced by these companies; and, in turn, offering our companies-in-residence a better understanding of the positive impact the FDA can have on the development of safer medical devices," she concluded.

- here is the announcement

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