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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 8th 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
• Current regulatory trends in the medical device industry

Proposed Topics for the Conference (Sept. 21-22, 2021):

• FDA Updates: CDRH and ORA
• Notified Bodies Updates
• International Updates
• COVID-19 EUA Lessons Learned
• Remote Regulatory Assessment
• Tissue-based Devices
• Digital Devices

The FDA and UGA will leverage their combined strengths for the joint development of this conference to meet these objectives.

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 clarity of information to stakeholders and the public. This conference is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as an example of outreach activities by Government agencies to small businesses.

Who Should Attend

The medical device conference will be attended primarily by industry representatives from the medical device community (i.e., Medical Service manufacturers and Innovators, Regulatory and Quality Assurance Professionals), Regulators and Academics. The regulatory professionals and academics in the biomedical sciences, experts and leaders in the medical device industry in US and abroad use the conference to stay informed on significant regulatory issues relating to current medical device manufacturing, compliance, quality assurance, lifecycle quality risk management, practical case studies, and global regulatory strategies. To learn more about the conference, please visit www.mdr-con.com

Contacts:

FDA: Trang Cox  [email protected]
UGA: Grace Gowda         [email protected]