We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility. Read More
The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval. Read More
Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system. Read More
FDA Commissioner Stephen Hahn said that the agency is not aware of any medical device shortages connected to the outbreak of the novel coronavirus — but the agency is aware of 63 manufacturers representing 72 facilities in China that produce essential devices that are prone to potential shortage if there is a supply disruption. Read More
The FDA issued a new policy that will allow certain laboratories to use validated COVID-19 diagnostics while the agency reviews their Emergency Use Authorization (EUA) requests. Read More
The FDA will hold a March 5 workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland. Read More
Taiwan’s legislature passed the Medical Device Management Law, separating the country’s regulation of medical devices from pharmaceutical products for the first time — and introducing new requirements for quality management systems. Read More
Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in a new status report. Read More
The FDA hit Draeger Medical Systems with a warning letter for failing to submit a new 510(k) premarket notification for “significant changes” it made to its patient monitoring device. Read More