FDA ISSUES DRAFT GUIDANCE FOR MEDICAL DEVICE DATA SYSTEMS
On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance to inform manufacturers, distributors, and other entities that FDA does not intend to enforce compliance with the agency’s 2011 regulations governing medical device data systems (MDDS) subject to 21 CFR §880.6310, medical image storage devices subject to 21 CFR §892.2010, and medical image communications devices subject to 21 CFR 892.2020, because of “the low risk they pose to patients and the importance they play in advancing digital health.”
MDDS are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS device does not modify the data or control the functions or parameters of any connected medical device, and are not intended to be used in connection with active patient monitoring. For example, an MDDS device may be used to collect data on a patient’s CO2 level from the patient’s ventilator and transmit this information to a central repository.
Although the guidance does not establish legally enforceable responsibilities, it does describe the agency’s current thinking on a topic. A copy of the guidance is available here. Comments on the draft are due within 60 days of its publication in the Federal Register. (Read more)