part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "G"
subpart_subject: "General Hospital and Personal Use Miscellaneous Devices"
section_number: "880.6310"
section_subject: "Medical device data system."
cfr_reference: "21 CFR 880.6310"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. (1) A medical device data system (MDDS) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
(i)The electronic transfer of medical device data;
(ii)The electronic storage of medical device data;
(iii)The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or
(iv)The electronic display of medical device data.
(2)An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.