The US agency sent 21 of the letters to device makers last year – the same number it mailed to firms in 2019.
Despite a year that saw on-site Food and Drug Administration inspections dwindle because of a pandemic, the US agency still managed to send 21 quality-related warning letters to device makers in calendar year 2020 – the same number it mailed to firms the year before.
FDA data shared with Medtech Insight show that of those 21 warning letters, 12 were issued to US companies and nine went to firms based outside the US. The agency...
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
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.
Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.
