FDA says some women still are not receiving information about the known risks of the Essure permanent contraception device before implantation, despite a boxed warning on the product and significant efforts to educate patients and doctors about the risks associated with the device.
Essure Birth-Control Device Hit With New Restrictions From US FDA
US FDA is placing more restrictions on the sale of Bayer's Essure permanent contraception device by requiring both patients and providers to read and sign off on a patient checklist highlighting adverse events.
More from Regulation
More from Policy & Regulation
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.