How innovators in the femtech space can protect their inventions and defend market share.
Guidance includes information about what’s protected—and what is not—when using period trackers and other health information apps on smartphones.
The company was accused of hiding serious health risks related to implantation of its transvaginal surgical mesh products.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.
Approved by FDA, the changes include a warning and a patient checklist that explains the risks and benefits of the permanent birth control device.