On January 24, 2013, the Office of Industry Engagement hosted an FDA Symposium entitled “Medical Devices and the FDA – Tips for Researchers.” FDA experts provided Georgia Tech faculty, researchers, and students with an overview of the types of medical devices, software, and apps that are subject to FDA regulations and guidelines. The sessions also offered best practices to ensure compliance with those processes during technology transfer and commercialization efforts.
“Many of our researchers work closely with industry partners as they bring new products into the marketplace,” said Kevin Wozniak, Executive Director of the Office of Industry Engagement. “This symposium provided the opportunity for Georgia Tech researchers to learn more about how FDA regulations may be relevant to their work.”
Highlights of the symposium included:
- An in-depth overview of the landscape relating to FDA regulation of mobile apps
- A lively discussion of Good Manufacturing Practice (GMP) compliance
- Concrete guidance on navigating the FDA clearance process for medical devices
The sessions enabled attendees to identify when and how a device, design, or manufacturing process may present a safety or effectiveness concern. The panel of experts also provided case studies and tangible tips for preparing submissions to the FDA.
All PowerPoint presentations and an audio file from the event are now available online.