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As part of postmarket surveillance, devicemakers should continuously monitor the performance of their devices, including for new potentially cross-reacting agents that could lead to inaccurate results, the group said. Read More
The EU’s Medical Device Coordination Group (MDCG) has clarified minimum performance requirements for devices intended to detect antibodies against the SARS-CoV-2 virus in a new guidance. Read More
The FDA should refine its processes for breakthrough device designation to better reflect the risks and benefits associated with such devices, researchers from three prominent medical schools advised in a New England Journal of Medicine article. Read More
The Center for Devices and Radiological Health (CDRH) gives devicemakers concrete examples of real-world evidence (RWE) used in premarket and postmarket submissions in a newly released report. Read More
These systems have not been shown to be accurate when used to take the temperature of multiple people at the same time and should not be used for mass temperature screening, the FDA said. Read More
The FDA’s Office or Regulatory Programs has sent letters to 25 manufacturers, distributors and sellers telling them to stop producing and issuing these certificates. Read More
A panel of the FDA’s Medical Devices Advisory Committee will meet virtually on April 6 to consider a premarket approval application for the TransMedics Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation of donor hearts intended for a transplant recipient. Read More
Australia’s Therapeutic Goods Administration is seeking industry input on whether it should adopt the EU Medical Device Regulation on nanomaterials in medical devices. Read More
The FDA is warning devicemakers that have been touting phony FDA registration certificates that give the false impression that their products have been cleared by the agency. Read More