Deviations, Devices, and Drugs: A Regulatory Roadmap for Human Tissue Reporting (Individual)

The tissue banking industry is undergoing an “era of opportunity” as the need for supplying the medical field with a variety of regenerative medicine solutions increases. As the regulatory paradigm has evolved, so have days of tissue banks marketing products exclusively regulated as Section 361 Human Cells, Tissues, and Cellular and Tissue-Based Products. In a regulatory world where tissue may be regulated as a Section 361 HCT/P, as a Section 351 HCT/P, or even as a medical device, the requirements for reporting adverse outcomes have never been more confusing to new and existing players in this emerging regulatory space for industry. Join John Mayhall, the Mayor of Regulationville, and Kip Hanks, AATB Director of Regulatory and Governmental Affairs, as we navigate the many regulatory pathways and requirements for human tissue product adverse outcomes reporting.

John Mayhall, MS

Regulatory Affairs Specialist II

StimLabs, LLC

John is a Regulatory Affairs Specialist II at StimLabs, LLC. John has a bachelor’s degree in microbiology from Auburn University and a Master’s Degree in Regulatory Affairs from the University of Georgia. John is an expert in the regulation of both HCT/Ps and medical devices, including Quality System regulations, submissions, registration and licensure.

Kip J. Hanks

Director of Regulatory and Governmental Affairs

After earning a BS in microbiology from McNeese State University and finishing up 6 years as a special operations forward air controller in the Louisiana Air National Guard, Kip Hanks began employment with the FDA as a field investigator in 1997. After a few years as a generalist covering multiple FDA-regulated products, he became a district biologics specialist and then the Office of Regulatory Affairs (ORA) biologics national expert. In this role, Kip was responsible for providing regulatory and guidance interpretation and application to ORA staff, training and mentoring new investigators, serving on policy and document workgroups and advising ORA senior leadership on biologics-related matters. In July 2021, he joined the American Association of Tissue Banks as its first director of regulatory and governmental affairs. In this role, Kip establishes and communicates the AATB official position regarding regulatory issues that may impact AATB member organizations to the FDA and other applicable governmental and standard-setting organizations. He provides expert interpretation, guidance, strategy and counsel on existing laws, regulations, standards, and guidance that impact AATB members.