Medical Device Data System

What Is This Device?

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.

How Is OUG Classified?

Medical Device Data System is FDA product code OUG, Class 1, 21 CFR 880.6310.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 24 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Software design (11), Device Design (3) and Software Manufacturing/Software Deployment (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.