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The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products —whether a drug, biologic product or device — in a new draft guidance released Friday.
A jury in the U.S. District Court for the Central District of California has awarded cardiac devicemaker Colibri Heart Valve $106.5 million for infringement by Medtronic’s CoreValve devices of Colibri’s patents for a self-expanding valve device used to replace diseased heart valves.
The European Medicines Agency (EMA) is launching a pilot program to offer scientific advice to manufacturers of certain high-risk medical devices, to help streamline their path to market.
The Medical Device Manufacturers Association (MDMA) and AdvaMed have called for several FDA actions to streamline and simplify the agency’s Voluntary Malfunction Summary Reporting(VMSR)program.
A citizen petition filed on behalf of the Clinical Decision Support Coalition has called on the FDA to rescind its September 2022 final guidance on Clinical Decision Support Software (CDS).
The U.S. Court of Appeals for the District of Columbia has rejected petitions from a cohort of drug and devicemakers that seek to overrule a decision last year allowing to proceed a lawsuit accusing the companies of indirectly funding terrorist acts in Iraq.
Companies can find it challenging to figure out the most efficient and compliant method to bring new medical devices to the U.S. market. A thorough understanding of the nuances involved in FDA regulation of new devices is necessary for companies to successfully launch new products in the U.S. without regulatory complications. Both regulatory and business factors must be considered.