OUG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Medical Device Data System

Device class

Class I (low risk)

Regulation

21 CFR 880.6310

Medical specialty

General Hospital

FDA definition

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.

Adverse events (MAUDE)

2021: 79 · 2022: 50 · 2023: 1,249 · 2024: 555 · 2025: 400 · 2026: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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