The Association of the European Self-Care Industry gives EU regulators a to-do list of targeted reforms to save the Medical Devices Regulation from the scrapheap.

Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers. 

FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

The Association of the European Self-Care Industry gives EU regulators a to-do list of targeted reforms to save the Medical Devices Regulation from the scrapheap.

Thousands of companies operating within the EU will soon be required to identify across their whole supply chain any adverse impact on the environment and human rights. Failure to do so could mean fines of up to 5% of worldwide net sales.

CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.