CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART G—General Hospital and Personal Use Miscellaneous Devices (§880.6025 to §880.6992) > 880.6310—Medical device data system.

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.

Code of Federal Regulations

[76 FR 8649, Feb. 15, 2011]

Code of Federal Regulations

Effective Date Note: At 76 FR 8649, Feb. 15, 2011, § 880.6310 was added, effective April 18, 2011.