Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh?
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FDA defines MDDS as any hardware or software that transfers, stores, converts, and or/displays medical device data. To be considered an MDDS, the product can’t modify either the data or its display. It also can’t, by itself, control the functions of a medical device. An MDDS isn’t supposed to be used for active patient monitoring. The FDA’s MDDS examples include software that:
• Stores patient data such as blood pressure readings for review at a later time
• Converts digital data generated by a pulse oximeter into a format that can be printed
• Displays a previously stored electrocardiogram for a particular patient
The Feb. 9, 2015, guidance, building on a June 2014 draft document, advises manufactures, distributors, and others involved that it “does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.” Industry should thank the FDA for acknowledging the low-risk nature of such devices. Further, the agency cited the “importance they play in advancing digital health.”
Specifically, the agency is giving out three free passes: MDDS previously subject to 21 CFR 880.6310, medical image storage devices previously subject to 21 CFR 892.2010, and medical image communications devices previously subject to 21 CFR 892.2020.
Comments, or applause, can be sent to the agency at www.regulations.gov. Cite document number 140021. The agency does point out, however, that comments might not be acted upon until the document is next revised or updated.
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