US FDA Warning Letters
The US FDA issued eight warning letters in September and October, with ultrasound, surgical and mobile apps among the affected product types.
US FDA inspections of three Philips manufacturing sites earlier this year resulted in a September warning letter that claimed the company was not in conformity with current good manufacturing practices. Philips says it is addressing the agency’s concerns and working to enhance its quality systems.
Two recent warning letters from the US FDA provide the companies with 30 business days to respond instead of the usual 15. Though not a regulatory requirement, the 15-day time frame has become the standard.
Dexcom has endured recalls, layoffs and leadership change, but interim CEO Jake Leach said the company remains committed to innovating next-gen devices.
The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.
Legal experts say a recent warning letter from the US FDA to a maker of dental products could upend a long-standing dental industry view that its operations and products are exempt from agency oversight.
The US FDA posted nine device-related warning letters in August, covering clinical research labs, laser therapy, orthopedics and more.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.
A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
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.