Suzanne O'Shea

Suzanne O'Shea

Faegre Baker Daniels

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Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

9/16/2014 - Chemicals FDA FDCA Medical Devices Prescription Drugs

What's Safety and Effectiveness Got to Do with Substantial Equivalence? FDA Clears it Up.

On July 15, 2014, FDA issued draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. We think of it as a...more

7/18/2014 - FDA Medical Devices Premarket Approval Applications Safety Precautions

Good News for Hospitals: FDA Eases Up on Medical Device Data Systems

A couple of years ago, FDA reclassified Medical Device Data Systems from a Class III product requiring premarket approval, to a Class I, 510(k) exempt product. Now the agency says that it doesn’t intend to enforce even the...more

6/23/2014 - FDA Healthcare Hospitals Medical Devices Premarket Approval Applications

POM Wonderful™ News for Prescription Drug and Device Manufacturers?

Last week, the Supreme Court decided that POM Wonderful™, maker of pomegranate juice, could sue Coca-Cola Company, maker of a blended juice product that included pomegranate and blueberry juices, under the Lanham Act for...more

6/19/2014 - Advertising Coca Cola False Advertising FDA FDCA Lanham Act Medical Devices Pharmaceutical POM Wonderful POM Wonderful v Coca Cola Prescription Drugs SCOTUS

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