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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
The FDA appears to be putting on the brakes to many requests for emergency use authorization (EUAs) for COVID-19 diagnostic tests, and industry experts say the FDA could be doing more to inform industry. Read More
Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods. Read More
SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR). Read More
The European Commission released new guidance explaining how Legacy Devices will be identified in the Eudamed database and how their unique device identifiers will be generated and assigned. Read More
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Read More
The FDA has named Kevin Fu as acting director of medical device cybersecurity within the Center for Devices and Radiological Health (CDRH) — a newly created position in response to the agency’s growing concerns about cybersecurity threats. Read More