Medical Device Legal News with Sam Bernstein: Episode 11
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more