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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.
Proov — a Colorado-based diagnostics company that makes the only FDA-cleared urine progesterone (PdG) test — has received a fourth patent for its at-home multi-hormone test for predicting ovulation.
The FDA has updated Medtronic’s November 2022 recall of its Mahurkar Acute Dual Lumen High Flow (13.5 French) hemodialysis catheters to Class I, due to a potential catheter hub defect that could cause the catheter tubes to leak, possibly leading to serious injury or death.