INRange Systems’ Citizen Petition

February 22, 2017 – The Food and Drug Administration received Inrange Systems’ February 13th citizen petition requesting that the agency take action to protect patient safety by detaining “LUMMA,” a product manufactured or sold by Life Integrating Technologies and Experiences, Inc.  In its petition, Inrange asserts that the LUMMA, a remote medication management system, is a “device” subject to the general controls of the Federal Food, Drug, and Cosmetic Act, including the establishment registration and device listing requirement described in 21 CFR § 807 Subpart B and premarket notification requirements described in 21 CFR § 807 Subpart E, and is therefore unapproved and misbranded within the meaning of Section 502(o) of the Act.

The docket number is FDA-2017-P-1002, filed on February 15, 2017.

By: Joyce L. Nadipuram