Medical Devices

HPM assists medical device manufacturers in understanding and managing all aspects of FDA’s regulation of medical device development, approval and clearance, manufacture and marketing.  HPM lawyers have worked on a wide range of medical device products including, for example, heart valves, excimer lasers, medical imaging devices, orthopedic implants, wound care, defibrillators, ophthalmic devices, medical software, and in vitro diagnostics.

Product Approval

HPM advises clients on premarket issues and approval strategies, including:

• Device Clearance/Approval Strategies
• Investigational Device Exemption (IDE) requirements
• Clinical Studies
• Premarket Notifications (510(k)s)
• Premarket Approval Applications (PMAs)
• De Novo Petitions
• Pre-Submissions
• Product Classification and Reclassification
• Humanitarian Devices
• Preparation for Panels
• Appeals of adverse regulatory decisions
• 513(g) Requests

Compliance and Post-Marketing Requirements

HPM has extensive experience in issues related to FDA regulation of marketed devices, including:

• Product Labeling, Advertising, and Promotion
• Establishment Registration and Product Listing
• Quality System Regulation (QSR)
• Medical Device Reporting
• Device Modifications
• Supplemental Applications
• Corrections and Removals
• Product Recalls

Professionals