Medical Devices and Radiological Health

We Guide You Through the Maze of Medical Device Regulations

Our Medical Device lawyers assist medical device manufacturers, distributors and importers with assistance in responding to and resolving medical device law issues relating to:

• Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s) and Investigational Device Exemption (IDE) Applications;
• Quality System Regulation (QSR) and the Medical Device Reporting Regulation MDR);
• FDA establishment inspections;
• Importation and exportation of medical devices;
• FDA 483s and Warning Letters;
• Recalls;
• Injunctions;
• Seizures;
• Advice on labeling, advertising, and promotion of medical devices;
• Establishment registration and medical device listing requirements;
• Representation in rulemaking, policy, enforcement, and litigation;
• Guidance, laws and regulations related to the manufacture and use of radiation emitting products;
• Information for mammography facility personnel, inspectors, and consumers;
• Counsel on proposed performance standards for electronic products;
• Information on whole body computed tomography (CT) scanning.

Helpful Links

Overview of Medical Device Regulation 
Is your Product Regulated? 
How to Market Your Medical Device 
Getting Your Radiation-Admitting Device to Market 
Importing and Exports Devices 
International Information 


PMA Decisions for October 2004

http://www.fda.gov/cdrh/newpg.html