Devices

FDA Hits Medical Device ‘Intended Use Creep’

Three SheppardMullin attorneys say FDA appears to be focusing enforcement on “intended use creep” that occurs when companies promote the capabilities of medical device software outside the scope of the intended use that was stated when the device was cleared. The attorneys’ online post discusses in detail a 6/21 Warning Letter to Zyto Technologies faulting promotion of its Hand Cradle Galvanic Skin Response device and associated software for uses outside the scope of the device’s 510(k) clearance.

The post also looks at a Warning Letter to iRhythm Technologies for promoting a remote monitoring device’s uses that were, according to the agency, outside the scope of the product’s 510(k) clearance.

“These enforcement actions indicate that FDA is keeping a close eye on the promotion of software-enabled medical devices, especially when that promotion suggests a function that has not been approved and/or cleared by FDA for the device,” the attorneys write.

Their post reviews the Zyto letter in detail and says its device system appears to have been an enforcement priority for the agency after the company failed to obtain 510(k) clearance for the software products as a “component,” despite a Warning Letter nearly eight years ago recommending that it do so.

“The fact that two of only a handful of medical device Warning Letters issued by FDA this year focus on the promotion of device software functions outside the scope of FDA clearance suggests a heightened focus on medical device software, in particular,” the post concludes. “Specifically, FDA is closely scrutinizing the addition of, and/or modification to, software that supports a device, as this has the potential to alter the functionality of the device itself and may jeopardize user safety if it is not developed and commercialized through the proper channels, especially if the software incorporates diagnostic and/or treatment capabilities. Product development teams should be familiar with the scope of a product’s intended use under an FDA marketing approval and/or clearance, and should remain vigilant about conducting testing and seeking expanded approval and/or clearance when the scope of the intended use is exceeded by new or modified product capabilities.”

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

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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