§ 880.6310 - Medical device data system.

§ 880.6310 Medical device data system.

(a) Identification.

(1) A medical device data system (MDDS) is a hardware 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, and interfaces, and a communications protocol. This identification does not include hardware devices intended to be used in connection with active patient monitoring. Hardware devices for active patient monitoring are classified under other regulations and are not included in this regulation.

(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, as amended at 86 FR 20283, Apr. 19, 2021]