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.
A user of SoClean’s device for cleaning continuous positive airway pressure (CPAP) devices is seeking a federal class action lawsuit against the company, claiming that the cleaning machine leaks toxic ozone gas. Read More
The FDA’s Special 510(k) application review can offer devicemakers the path of least resistance to market clearance, an official from the FDA’s Center for Devices and Radiological Health (CDRH) said, as long as the device meets specific criteria. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic drug-device combination products if the generic product’s user interface is substantially different from the original product. Read More
The Association of Medical Device Reprocessors (AMDR) has issued an update on global regulatory standards for single-use medical device reprocessing and remanufacturing. Read More
Two separate lawsuits in the federal courts are claiming that Philips Respironics’ continuous positive airway pressure (CPAP) devices caused lung cancer, in one case leading to a death. Read More
A bipartisan bill that has been referred to the Senate Committee on Health, Education, Labor and Pensions would mandate that the FDA frequently update its cybersecurity guidelines to help ensure that devices are protected against cyberattacks. Read More
The FDA said Friday that it is withdrawing guidance it issued in June 2020 — three months after the beginning of the pandemic — on formal meetings and user fee applications for devices. The withdrawal is effective July 7. Read More
The FDA has issued final guidance that details what information should be included in premarket submissions to show electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions and sensors. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) said it is now accepting all presubmissions for in vitro diagnostics (IVDs), including non-COVID-19-related products, effective June 1. Read More
Two lines of Becton Dickinson (BD) devices that rely on software can be hacked relatively easily, the U.S. Cybersecurity and Infrastructure Security Agency said, deeming both to be vulnerable to “low-attack complexity.” Read More
San Diego, Calif.-based Quidel has completed its $6 billion acquisition of Ortho Clinical Diagnostics, creating what the newly merged company, QuidelOrtho, calls a “balanced and diversified” portfolio of diagnostic instruments and assays. Read More
Guardant Health has moved to dismiss a lawsuit Illumina filed against it for allegedly stealing trade secrets relating to next-generation sequencing oncology tests. Read More