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
Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice.
The...more
6/19/2019
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Labeling ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Preemption ,
Prescription Drugs ,
Product Defects ,
Product Labels ,
Public Health ,
Supremacy Clause