FDA Policy/General

Enforce Regulation of ‘Wellness’ Devices: Petition

A Spark Biomedical petition asks FDA to enforce proper regulation of “wellness” devices. Spark markets the FDA-approved Sparrow transcutaneous auricular neurostimulation system. The petition specifically asks that FDA:

ensure that all neurostimulation wellness products claiming to “cure” or “treat” medical conditions are subject to the same regulatory standards as FDA-approved neurostimulation medical devices;
remove from the market any neurostimulation wellness products that make unsubstantiated medical claims; and
require companies selling neurostimulation wellness products to amend their advertising and promotional materials to eliminate any false or misleading medical claims.

Spark says it submitted the petition “to highlight industry concerns regarding the misbranding and sale of neurostimulation wellness products in the U.S. that make false and misleading medical claims.” It specifically cites auricular vagus nerve stimulation, transcranial direct current stimulation, and cranial electrotherapy stimulation, which it says are currently marketed as capable of curing or treating serious medical conditions despite lacking FDA approval or clearance on the claims. “These products are easily accessible online and heavily promoted on social media platforms … reaching a broad audience without adequate regulation,” the petition says…. “We urge FDA to take decisive action to protect consumers by regulating these wellness products and enforcing compliance with existing laws and regulations.”

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