The FDA hit UK-based devicemaker Bedfont Scientific with a warning letter for quality failures and the handling of data. Source: The GMP Letter

TEAM-NB, the European Association of Notified Bodies for medical devices, reported that CE certificates spiked by nearly 50 percent last year. Source: The GMP Letter

The Medical Device Innovation Consortium (MDIC) is asking for feedback on its new draft framework for using real-world evidence (RWE) in the development and clearance of in-vitro diagnostics (IVDs). Source:…

The EU’s Medical Device Coordination Group released a guidance for devicemakers on transitional provisions for Class I devices under the Medical Device Regulation (MDR). Source: The GMP Letter

The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Source: The GMP Letter

Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Source: The…

The FDA cited six U.S. devicemakers for a variety to quality failures including failing to submit medical device reports or to maintain a device master record. Source: The GMP Letter

To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Source: The GMP Letter

Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Source: The GMP Letter

The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Source:…