The US Food and Drug Administration released two warning letters and two close-outs last month, with one close-out resolving a finding the Owlet Smart Sock was being sold without FDA approval.
Check out Medtech Insight's US FDA Warning Letter Data Tracker here.
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HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The deadline for comments is 30 June 2025
Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.
Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.
The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.
