Permission Granted: D.C. Circuit Preserves Medical Device Repair Access
Key Takeaway(s): Medical device companies should treat copyright as just one part of a layered protection strategy. The DMCA repair exemption preserves meaningful access for qualifying third-party diagnosis, maintenance, and...
AI-Enabled Medical Devices Require an Integrated FDA and IP Strategy
Key Takeaway: Medical device companies should prepare a cohesive patent and premarket submission strategy by considering FDA recommendations when developing AI-enabled features and coordinating statements made to the Patent Office...
FDA to Hold Public Meeting on Proposed Medical Device Review Recommendations
Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device...
Subscribe for News and Updates
