Inrange Requests FDA to Detain Medication Management System

September 18, 2015 – Inrange Systems, Inc. requested the FDA to detain all existing models of LUMMA Remote Medication Management Systems, which is manufactured or sold by Life Integrating Technologies and Experiences, Inc.  Inrange alleges that LUMMA is not cleared or approved by the FDA and is misbranded within the meaning of Section 502(o) of the Federal Food, Drug, and Cosmetic Act (“the Act”).  Inrange further alleges that “[t]his device does not; (i) conform to the general controls of the Act, including the establishment registration and device listing requirements described in 21 CFR §807 Subpart B and the premarket notification requirements described in 21 CFR §807 Subpart E; (ii) address, as determined by the [] FDA, the special controls which, when combined with the general controls of the Act, shall be sufficient to provide reasonable assurance of the safety and effectiveness of such devices in light of the specific risks to health associated with such devices; and (iii) did not obtain a substantial equivalence determination from FDA prior to marketing such devices.”

By:  Christopher J. Stankus

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