Devices

FDA Sends Warning Letters to Makers of Breast Binders

FDA says it has begun enforcement actions against companies illegally marketing breast binders to children, placing the agency’s role at the center of a broader federal crackdown announced by HHS on what it calls sex-rejecting medical procedures for minors. The agency says it is issuing Warning Letters to 12 manufacturers (see the 12/18-dated letters here) and retailers for marketing breast binders to children for the treatment of gender dysphoria, a use the agency says violates federal law. Breast binders are regulated as Class 1 medical devices intended for limited purposes such as post-mastectomy recovery, not for pediatric use tied to gender-related treatment. Commissioner Marty Makary says the agency is prepared to escalate enforcement if the companies do not correct the violations, including through import alerts, product seizures, or court injunctions.

The FDA action was unveiled as part of a sweeping HHS announcement detailing proposed regulatory and enforcement steps across multiple agencies. HHS said the measures are intended to implement an executive order from President Trump directing the department to end what the administration describes as sex-rejecting procedures for children.

Beyond FDA’s Warning Letters, other actions include forthcoming rulemakings from the Centers for Medicare & Medicaid Services to restrict hospital participation in federal programs if they perform certain gender-related interventions on minors. CMS plans to propose barring hospitals from conducting such procedures on patients under 18 as a condition of participation in Medicare and Medicaid, a move that could affect nearly all U.S. hospitals.

HHS Secretary Robert F. Kennedy, Jr. also signed a declaration asserting that these procedures do not meet professionally recognized standards of care, citing an HHS peer-reviewed report. Under the declaration, practitioners performing such procedures on minors would be deemed out of compliance with those standards, the department said.

In addition, HHS highlighted its peer-reviewed report reviewing evidence on pediatric gender dysphoria treatments and a new public health message from the U.S. Public Health Service warning that current evidence does not support claims that puberty blockers, cross-sex hormones, and related surgeries are safe and effective for children.

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