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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.
The European Medicines Agency (EMA) is taking on a new role in monitoring and mitigating medical device shortages during public health emergencies, through a yet-to-be-created Medical Devices Shortages Steering Group (MDSSG).
Device developers and other stakeholders are encouraged to include both on-site and virtual site proposals and to address patient engagement as a supplemental topic.
Manufacturers can now submit proposals to participate in the Center for Devices and Radiological Health’s (CDRH’s) Experiential Learning Program (ELP), an on-site or virtual visit program that gives CDRH staff an opportunity to better understand the device development life cycle.