The U.S. Food and Drug Administration (FDA) has reportedly sent warning letters to several medical device manufacturers for violations of its device marketing and good manufacturing practices requirements.
According to a news item posted to the website of the Regulatory Affairs Professional Society (RAPS), the FDA recently sent warning letters to three different medical device companies. In at least one case, a company was cited for promoting the use of its devices to treat medical issues that are outside the scope of the device’s authorization.
In other cases, the companies were cited for their failure to implement current good manufacturing practices (CGMP) in connection with some of their products.
The companies reportedly cited by the FDA include Mectronic Medicale, a manufacturer of devices used to heat tissue to alleviate pain and muscle spasms, Visgeneer, which develops blood glucose monitoring systems, and Oasis Medical, a California-based drug company.
The RAPS article regarding the FDA’s warnings regarding non-compliance by device manufacturers is available at https://www.raps.org/news-and-articles/news-articles/2025/8/fda-issues-warning-letters-for-cgmp-violations,-ma.
