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Title 21 Part 880 → Subpart G → §880.6310

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6310

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6310

e-CFR data is current as of October 17, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6310


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§880.6310   Medical device data system.

(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.

[76 FR 8649, Feb. 15, 2011]


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