FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; HEMATOLOGY AND PATHOLOGY DEVICES; CLASSIFICATION OF THE DIGITAL CERVICAL CYTOLOGY SLIDE IMAGING SYSTEM WITH ARTIFICIAL INTELLIGENCE ALGORITHM

WASHINGTON, Nov. 5 -- Food and Drug Administration has issued a rule called: Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm.

The rule was published in the Federal Register on Nov. 5 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the digital cervical cytology s...