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
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations.
Generic preemption remains a hot topic. In Storm...more
10/10/2015
/ 510(k) RTA ,
Device Classification ,
Drug Safety ,
Failure To Warn ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Pharmaceutical Industry ,
Preemption ,
Product Labels ,
Transvaginal Mesh