Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
12/9/2022
/ 510(k) RTA ,
Classification ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medtronic ,
Regulatory Standards ,
Risk Assessment ,
Risk Management ,
SCOTUS ,
Standards & Procedures