Medical Device Legal News with Sam Bernstein: Episode 9
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more
The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more