The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more
2/3/2020
/ 510(k) RTA ,
Artificial Intelligence ,
Deregulation ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Medical Devices ,
Premarket Approval Applications ,
Public Workshops ,
Regulatory Burden ,
Regulatory Reform ,
Software
The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
12/20/2019
/ 510(k) RTA ,
FDA Approval ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pre-Market Notification ,
Premarket Approval Applications ,
Prescription Drugs ,
Regulatory Burden ,
Statutory Interpretation ,
Venture Capital
Background: The Increasing Regulation of Medical Devices Subject to 510(k) Clearance -
The U.S. Food and Drug Administration's (FDA's) 510(k) premarket clearance pathway is the road to commercialization for thousands of...more
Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more