Devices

InRange Systems Wants Lumma Medication Device Detained

InRange Systems says FDA should detain the Life Integrating Technologies and Experiences Lumma remote medication management system which has not been cleared or approved by the agency and is misbranded. The InRange petition says the Lumma device does not (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act, including the establishment registration and device listing requirements; (2) address the special controls which, when combined with the act’s general controls, are sufficient to provide reasonable assurance of the safety and effectiveness of devices in light of specific risks to health associated with such devices; (3) have a substantial equivalence determination from FDA that was obtained before marketing.

“This is the second request we have made about this device and request that action be taken,” the petition says. It asks that if the agency rules favorably on the petition, it then seize all existing models of the Lumma remote medication management system presently on the market.

According to InRange, FDA ruled that in-home medication management devices that can be remotely controlled are Class 2 medication devices. It says that the Lumma device is an unapproved and misbranded device as it has the same intended functions and intended use as generic remote medication management system devices.

“The potential risks to patient safety resulting from this device require that immediate action be taken to require Life Integrating Technologies and Experiences Inc. to conform to the general controls of the act, including the establishment registration and device listing requirements … and the premarket notification requirements…,” the petition says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome