With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.
US FDA is requiring Bayer AG to follow the medical condition of women implanted with its Essure permanent birth control device for five years instead of three years. The decision comes on the heels of a number of high-profile reports and a documentary spotlighting the safety concerns with the device and FDA's oversight role.
On Dec. 20, FDA Commissioner Scott Gottlieb said that on top of all the requirements the agency has put...
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
