FDA released two new guidelines about Global Unique Device Identification Database (GUDID) and Medical Device Data Systems (MDDS).
The GUDID Guidance was finalized in phases. The first phase was released on June 11, 2014 and provided general information to labelers to enable them to obtain a GUDID account and begin initial submissions to the GUDID. Now, in a single document, all sections of the draft guidance are being finalized, and the document has hence to be considered as definitive.
The Guidance Document about Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices is still a Draft. This document was issued in order to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS (21 CFR 880.6310), medical image storage devices (21 CFR 892.2010), and medical image communications devices (21 CFR 892.2020), due to the low risk they pose to patients and the importance they play in advancing digital health.
For further details: