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The FDA slapped Centaur Pharmaceuticals with a 10-observation Form 483 after investigators observed destruction of good manufacturing practice (GMP) documents, among other serious lapses. Read More
The Federal Trade Commission (FTC) is ramping up its oversight of health data collected electronically and plans to issue a new rule on notifications of health breaches to clarify the existing rule’s applicability to health apps and other similar technologies. Read More
A U.S. district judge in Minnesota has issued a judgment against Precision Lens and its owner, Paul Ehlen, to pay $487 million after a civil jury found them guilty of offering kickbacks to doctors performing Medicare-reimbursable surgeries. Read More
One-third of the healthcare-related suits brought by the Department of Justice (DOJ) in 2022 concerned medical device manufacturers, pharmaceutical wholesalers and retailers, focusing particularly on violations of anti-kickback and Stark Law violations and including individuals as well as companies. Read More
CDRH Director Jeffrey Shuren aims to reverse a historical trend and make the U.S. the top destination for novel medical device launches, improving the center’s efficiency along the way. Read More
Philips Respironics reports risk assessments of its continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) sleep apnea therapy devices showed that degraded sound abatement foam on the devices would likely not cause “appreciable harm” to patient health. Read More
Among devices subject to an FDA Class I recall from 2018-2022, only one-quarter of recall notices included adequate information to accurately identify the device or component at fault, according to a new study. Read More
The EU Commission’s latest guidance on its new medical device regulations provides a detailed explanation of the required content, as well as the structure, for the summary of a report on the results of a clinical investigation. Read More
Netherlands-based devicemaker Philips has agreed to pay $62 million to settle charges made by the U.S. Securities and Exchange Commission (SEC) that it “engaged in improper conduct to influence foreign officials ... to increase the likelihood that Philips’ products were selected” as well as using improper bidding practices in China between 2014 and 2019. Read More