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U.S. Food and Drug Administration (2023). Center for Drug Evaluation and Re-search. Waivers, Exceptions, and Exemptions from the Requirements.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act

has been cited by the following article:

• TITLE: Medical AI: The Process of Adoption

  AUTHORS: Frank Schuller, Ignacio Fuentes Ribas, Grayson Ahmed

  KEYWORDS: Adoption, AI Regulation, Artificial Intelligence, Diagnostics, Healthcare, Implementation, Innovation, Predictive AI, Resistance, Technology

  JOURNAL NAME: Open Journal of Business and Management, Vol.14 No.2, March 6, 2026

  ABSTRACT: Implementation and adoption of innovation, in most cases, initially confronts resistance and skepticism from end-users. For medical innovations, the impediments are redoubled with concerns about patient safety, regulation, and the therapeutic benefits. This article examines the potential hindrances by hospitals and physicians in embracing potentially transformative technologies, such as predictive artificial intelligence for cancer. The analysis formulates specific recommendations that can ease implementation against the countercurrents to innovation. The article concludes with an example of an effective strategy of a hospital’s capable integration of AI into the system with the collaboration of an information technology company.