MEDICAL DEVICES: DESCRIPTION

McKenna Long & Aldridge helps trade associations, manufacturers and distributors of medical devices on issues ranging from regulatory strategy development and premarket clearance procedures to efforts to lessen product liability exposure of marketed devices. Among other services, we:

• Develop regulatory strategy documents and corporate policy drafts
• Represent clients facing FDA enforcement litigation and in formal and informal administrative hearings
• Represent clients in enforcement proceedings brought by FDA under the Radiation Control Act
• Plan, oversee and assist with fraud investigations and regulatory and due diligence investigations for public financings and acquisitions