- November 28 - 30, 2023
- Organized By:
Location: University of Georgia Center for Continuing Education and Hotel in Athens, GA and Online via Zoom
Conference Registration | Virtual and In-person
November 28-29, 2023 (Conference)
*Workshop Registration | Virtual and In-person
November 30, 2023 (Workshop*)
* Workshop solely sponsored by UGA.
The Board of Regents of the University System of Georgia by and on behalf of the University of Georgia College of Pharmacy, Institute of International Biomedical Regulatory Sciences (“UGA”) and the Atlanta District of the Food and Drug Administration (“FDA”) are co-sponsoring the 10th Annual FDA/UGA Medical Device Regulations Conference for the medical device industry and those who interact with them.
UGA College of Pharmacy jointly developed the Medical Device Regulations Conference with FDA to facilitate understanding and collaboration between highly experienced professionals and technical experts from the FDA and industry on medical device issues. This conference carries out FDA’s mission to protect the public health and fulfill UGA’s educational and service missions.
Through a series of plenary and sessions, this conference will provide opportunities for attendees to learn about critical issues and current thinking in medical device regulations.
Goals and Objectives
The Medical Device Conference was established to provide educational and networking opportunities to help shape the future of medical device advancement from a regulatory science perspective. Using a tutorial approach, experienced leaders from the FDA, industry, and academia will present and engage the audience on issues related to strategic and tactical implications of FDA’s medical device regulations.
Aligned with the strategic priorities of the FDA, this conference seeks strategic solutions to complicated issues.
These challenges include:
- Designing products with the patients in mind
- Addressing compliance and submission concerns
- Risk management throughout the life cycle of the device
- Risk management as part of design control
- Human Factors/Usability testing as part of risk management
- Current regulatory trends in the medical device industry
Visit: https://www.fda.gov/about-fda/ora-program-areas/medical-device-radiological-health for additional information on ORA’s Medical Device & Radiological Health program area.
FDA: Anne Reid Anne.Reid@fda.hhs.gov
UGA: Michael G. Bartlett firstname.lastname@example.org
Participation in this conference supports objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarify of information to stakeholders and the public. This conference is also consistent with the Small Business Regulatory Enforcement Act of 1996 (Public Law 104-121), as an example of outreach activities by Government agencies to small businesses.