The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
8/22/2025
/ 510(k) RTA ,
Artificial Intelligence ,
Cybersecurity ,
Digital Health ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Manufacturers ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Regulatory Oversight ,
Regulatory Requirements ,
Software
The U.S. Supreme Court recently issued an important opinion in Alice Corp. v. CLS Bank International regarding the patent eligibility of basic business methods covered in computer software patents. Writing for the unanimous...more
6/24/2014
/ Alice Corporation ,
Bilski ,
CLS Bank ,
CLS Bank v Alice Corp ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Risk Mitigation ,
SCOTUS ,
Software
The U.S. Supreme Court issued an important opinion today in Alice Corp. v. CLS Bank International regarding the patent eligibility of basic concepts covered in computer software patents. Writing for the unanimous Court,...more