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Vericel has submitted a humanitarian device exemption supplement to the FDA to revise the labeled indications of Epicel to specifically include use in pediatric patients. Read More
The FDA has issued new guidance clarifying the processing and technical standards for electronic copies for medical device submissions, based on the agency’s experience so far with the program. Read More
The FDA is reopening the comment period for feedback on challenges and opportunities of regulating next-generation sequencing-based clinical tests, responding to requests from stakeholders who need additional time to submit input. Read More
Australia’s Therapeutic Goods Administration has revised its guideline on how manufacturers should classify in vitro diagnostics based on risk. Read More
Manufacturers of electrically powered medical devices should provide information, such as summary testing and specifications, to demonstrate their products don’t pose a risk of electromagnetic interference. Read More
Citing continued violations of a 2007 consent decree, the FDA has ordered Custom Ultrasonics to recall all 2,800 automated endoscope reprocessors in hospitals and outpatient clinics in the U.S. Read More
Hospitals and other healthcare institutions must follow certain administrative measures for quality supervision on the use of medical devices, under a new regulation issued by China’s FDA that focuses on procurement, maintenance, supervision and documentation. Read More
The FDA is aiming to develop additional documents and policies to help investigators and devicemakers understand Critical to Quality factors. Read More
With an eye toward ensuring patient safety, Malaysia’s Medical Device Authority has provided its thinking on how companies should report incidents involving medical devices. Read More
Olympus America, Fujifilm Medical Systems and Pentax’s Hoya unit had to submit postmarket surveillance studies to the FDA detailing how their duodenoscopes are reprocessed in healthcare facilities. Read More