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Cyberattacks have become a routine occurrence, prompting radical changes in the way device manufacturers think about the problem, all the way back to the design stage, according to a panel discussion Tuesday at the Food and Drug Law Institute’s annual conference. Read More
The Verifying Accurate Leading-edge IVCT Development (VALID) Act was included as part of user fee reauthorization legislation that passed through the Senate Committee on Health, Education, Labor and Pensions (HELP) Tuesday in a 13 to 9 vote. Read More
The EU’s Medical Device Coordination Group (MDCG) is warning device companies that they risk not being able to market their previously approved products in Europe if they are not in compliance by the time the transitional period for the Medical Device Regulation (MDR) ends on May 26, 2024. Read More
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