Daily Briefing

Around the nation: FDA expands Early Alert program to all medical devices


FDA has expanded its Early Alert program to include all medical devices, giving the healthcare industry more visibility into potential safety issues with medical devices, in today's bite-sized hospital and health industry news from Iowa, Maryland, and Texas. 

  • Iowa: Robert Ritz, president and CEO of MercyOne, will retire from the health system Jan. 2, 2026. In 2013, Ritz joined MercyOne as president of Mercy Des Moines Hospital before becoming CEO of Mercy Health Network in 2017. Mercy Health Network was later rebranded as MercyOne and is co-owned by CommonSpirit Health and Trinity Health. According to Becker's Hospital Review, Ritz oversaw MercyOne's ownership transfer to Trinity Health and led the acquisition of Genesis Health System, which is now known as MercyOne Genesis. Currently, MercyOne has 40 owned and affiliated hospitals and hundreds of clinics. Trinity Health plans to start recruiting for Ritz's successor over the next few months. (Kuchno, Becker's Hospital Review, 9/30)
  • Maryland: FDA last week expanded its Early Alert program to include all medical devices. The program, first piloted by the Center for Devices and Radiological Health in November 2024, is designed to reduce the time between FDA first learning of a product being removed or modified and when providers and patients are notified. Early notices allow people to know when manufacturers remove products, update instructions, or make corrections due to safety risks — even before FDA confirms an issue meets the definition of a recall. Under the program's expansion, FDA will now issue early alerts for all medical devices, which will allow the healthcare industry to identify potential high-risk issues with medical devices more easily. (Bean, Becker's Hospital Review, 9/30)
  • Texas: U.S. District Judge Matthew Kacsmaryk declined to dismiss a lawsuit against FDA that aims to restrict the abortion medication mifepristone. Instead, he transferred the case to the Eastern District of Missouri "in the interest of justice." Previously, the U.S. Supreme Court dismissed the original lawsuit, ruling that private parties had no legal basis to challenge mifepristone access and that plaintiffs did not show that they had been personally harmed by government regulation of the drug. According to The Hill, transferring the case to Missouri means that a judge could potentially rule to reinstate prior restrictions on mifepristone or revoke the medication's approval altogether. In a statement, Evan Masingill, CEO of mifepristone manufacturer GenBioPro, said he was disappointed that the case wasn't dismissed. "Mifepristone has been approved by the FDA for a quarter century using their rigorous standards," Masingill said. "Any attempt to roll back access to mifepristone infringes on Americans' reproductive freedom and will jeopardize the health of millions nationwide. GenBioPro remains committed to ensuring affordable, science-based access to medication abortion for all who need it." (Weixel, The Hill, 10/1)

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