On Jan. 7, 2025, the FDA issued its draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” In its latest draft guidance on medical devices, the FDA provides recommendations on the documentation and information that should be included in marketing submissions for devices that include AI-enabled device software functions.

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Photo of Kyrie’ Chandler Kyrie’ Chandler

Kyrie’ Chandler represents clients in defense of product liability, premises liability, medical malpractice, and personal injury litigation matters. Her clients have included Fortune 500 companies, insurance carriers, and a major metropolitan transit authority.

Kyrie’ manages all aspects of litigation, including drafting pleadings, conducting…

Kyrie’ Chandler represents clients in defense of product liability, premises liability, medical malpractice, and personal injury litigation matters. Her clients have included Fortune 500 companies, insurance carriers, and a major metropolitan transit authority.

Kyrie’ manages all aspects of litigation, including drafting pleadings, conducting written and deposition discovery, preparing for and taking depositions, and drafting various motions such as motions to dismiss, motions for summary judgment, and response motions.

In her practice, Kyrie’ has second-chaired a hearing on a motion to enforce settlement agreement and has assisted with motions drafting and pleadings as local counsel for a national, multicase/multiplaintiff hair relaxer matter. Kyrie’ has also represented a major southeastern convenience store corporation in a successful motion to dismiss and defended Georgia’s largest hospital in a medical malpractice action.

Photo of Beth K. Toberman Beth K. Toberman

Beth K. Toberman is Co-Chair of the Atlanta Products Liability Litigation Group. Beth has a national practice focusing on counseling and assisting clients in eDiscovery and information management in complex litigation, ranging from pharmaceutical and medical device litigation to securities and other commercial…

Beth K. Toberman is Co-Chair of the Atlanta Products Liability Litigation Group. Beth has a national practice focusing on counseling and assisting clients in eDiscovery and information management in complex litigation, ranging from pharmaceutical and medical device litigation to securities and other commercial litigation, as well as internal and governmental investigations. She regularly provides guidance on a full range of eDiscovery issues, including records retention and management, management of electronically stored information (ESI) before and during litigation, and coordinating the overall strategy for preservation, collection, review and production of ESI in active litigation.

Beth has served as eDiscovery counsel on matters for Fortune 500 pharmaceutical, medical device and financial institution clients. As part of these representations, Beth has worked with in-house counsel to develop eDiscovery strategies covering the entire spectrum of the eDiscovery process, from document identification to production and everything in between, including vendor selection and the defense of privilege logs.