FDA Practice

Ice Miller's Food and Drug Administration ("FDA") practice encompasses a wide range of drug and medical device services including the provision of regulatory compliance advice, counseling institutional review boards, and assisting clients in classifying medical devices and obtaining device exemptions and premarket approvals. Our medical device practice specifically entails assisting clients with the following:

• Medical device classification determination;
• Premarket 510(k) exemptions;
• 510(k) premarket notification;
• Substantial equivalency determination;
• Premarket approval of devices;
• Establishment registration;
• Medical device listing;
• Investigational device exemptions;
• Labeling compliance;
• Medical device monitoring and reporting;
• Good manufacturing practices and quality systems;
• Medical device recalls; and
• Post-market surveillance.

Click here to find out more about FDA Practice