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The agency currently treats clinical data as confidential business information and only releases it if needed to protect public health or safety. Read More
A recently implemented decree by France’s Agency for the Safety of Health Products (ANSM) requires manufactures of Class III and implantable medical devices to provide new summaries of product characteristics when a device is put into service. Read More
The FDA is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the device development process. Read More