CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR880.6310]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart G - General Hospital and Personal Use Miscellaneous Devices

Sec. 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 electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, and interfaces. 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]