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Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems

#1
HI,

We are making a medical device which docks onto a MDDS gateway for charging and data transfer. We are also thinking to use MDDS gateway as a means to upgrade the firmware of the medical device.

According to FDA guidance MDDS is defined as "Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device".

By performing the firmware upgrade via MDDS gateway, we believe we can still be MDDS since MDDS gateway is controlling the functions of the device by itself. or does it violate the definition of MDDS?
 
#2
Hi Hemanth,
It's not clear to me what you hope to achieve from regulatory standpoint. Below is the exact definition for MDDS from 21 CFR 880.6310:

Sec. 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.


It seems to me that once you alter the firmware of a medical device through MDDS it goes outside scope of what MDDS is and does.

Shimon
 
#3
Hi Shimon,

From a regulatory standpoint, The FDA does not intend to enforce compliance with the regulatory controls that apply to the following devices: a) MDDS subject to 21 CFR 880.6310, which means the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.

We have to look at different means of firmware upgrade now.
 
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