Senior Writer, US Policy & Regulation
Brian holds a BA in history from Loyola University of New Orleans, is a die-hard Saints fan, and loves running, classical music and jazz. He lives with his wife, Caroline, in New York’s magnificent Hudson Valley.
Latest From Brian Bossetta
The FDA’s recent proposal to allow hearing aids to be sold over the counter without a prescription has mostly been met with approval. Many Americans, however, are unaware of the plan.
In a letter to CMS Administrator Chiquita Brooks-LaSure, the industry association argues that repealing MCIT would deny many Americans access to “transformational” medical technologies.
The Affordable Care Act requires health insurers to cover contraceptives; some lawmakers in the US House want to make sure those requirements are upheld.
The US FDA issued a safety communication to patients and health care providers about the potential for overdose when using ENFit low dose tip syringes, and also told manufacturers to update labeling to account for the risk.
The US FDA’s most recent guidance revises UDI requirements for class I and unclassified medical devices the agency issued in July. Class I devices categorized as consumer health products will be exempt from some submission requirements.
The Ninth Circuit Court of Appeals upheld a lower court’s decision that false advertising claims made against Siemens Medical Solutions by a competitor had no basis for trial.