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The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More
The current formal agreement “needs to be updated to reflect organizational and procedural changes that have occurred since 2018” the report says. Read More
To regulate new medical device technologies, the FDA should rely on familiar regulatory processes to review low-risk activities while adopting a more attentive approach that devotes greater resources to high-risk activities, according to a former agency commissioner. Read More
BioTelemetry, owned by Philips, and its subsidiary LifeWatch Services have agreed to pay more than $14.7 million to resolve allegations that they violated the False Claims Act by knowingly submitting claims to federal government programs for a higher level of cardiac monitoring than physicians intended to order. Read More
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More
Apple decided on its own to stop selling the contended watches in December, well before the ban would have gone into effect following a presidential review, Masimo said. Read More
A five-year-old agreement between the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) on medical device cybersecurity should be updated to reflect new practices, according to a recent report by the U.S. Government Accountability Office (GAO). Read More
While Apple’s request earlier this week for an interim stay of federal orders to stop selling its watches is hardly an emergency, according to Masimo, a federal court has agreed to Apple’s request and issued a temporary stay on the ban. Read More
As if lawsuits and plummeting stock prices from its faulty CPAP machines didn’t provide enough bad headlines, Philips now wants customers to pull the plug on one of its magnetic resonance imaging machines due to the potential for an explosion. Read More