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Evolution of FDA regulation of AI-based technology
14 June 2022
PartnerPhiladelphia
Email [email protected]hoganlovells.com
Phone +1 267 675 4687
Fax +1 267 675 4601
LanguagesEnglish, French
Practice groupGlobal Regulatory
Kelliann Payne's science education and background in the medical device industry allow her to quickly understand emerging medical device technology, including digital health products, and informs her current focus on related legal and business issues. Her experience includes the development, regulation, advertising, and litigation of medical devices and digital health products, including machine learning-based clinical decision support software.
Kelliann drafts premarket submissions for diagnostic and therapeutic medical devices, evaluates and formulates applicable regulatory strategies, and reviews the accuracy of marketing claims. She helps companies in their preclinical and clinical programs and leads due diligence reviews for investments and acquisitions.
In her role as Assistant General Counsel at QVC, Inc. from 2013 to 2014, Kelliann counseled internal clients on Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations applicable to health, wellness, beauty, and cosmetic products.
As a consultant for the medical device industry, she assisted companies with complex regulatory challenges and strategies for marketing innovative products. Kelliann majored in biology prior to pursuing a career in law.
Education
J.D., The Catholic University of America, Columbus School of Law, 2005
B.S., The Catholic University of America, 1998
Bar admissions and qualifications
Pennsylvania
District of Columbia
Interacts regularly with FDA staff on premarket medical device submissions.
Counsels the beauty industry regarding requirements for aesthetic medical devices.
Reviews advertising and promotional materials for compliance with FDA and FTC regulations.
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