FDA Regulation of Laboratory Clinical Decision Support Software: Is It a Medical Device?

Abstract

Journal Article FDA Regulation of Laboratory Clinical Decision Support Software: Is It a Medical Device? Get access Ronald Jackups, Jr. Ronald Jackups, Jr. Associate Professor, Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO Address correspondence to this author at: Campus Box 8118, 660 S. Euclid Ave., St. Louis, MO 63110. Tel 314 362 3186; e-mail [email protected]. Search for other works by this author on: Oxford Academic Google Scholar Clinical Chemistry, Volume 69, Issue 4, April 2023, Pages 327–329, https://doi.org/10.1093/clinchem/hvad011 Published: 20 February 2023 Article history Received: 31 October 2022 Accepted: 23 January 2023 Published: 20 February 2023

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