Hyman Phelps and McNamara
 
Medical Devices
 
HPM assists medical device manufacturers in understanding all aspects of FDA's regulation of medical device development, approval and clearance, manufacture and marketing.

Product Approval

HPM advises clients on premarket issues and approval strategies, including:
  • Investigational Device Exemption (IDE) requirements

  • Clinical Studies

  • Custom Devices

  • Premarket Notifications (510(k)s)

  • Premarket Approval Applications (PMAs)

  • Product Classification and Reclassification

  • Humanitarian Devices

  • Device Approval Strategies

  • Preparation for Panels

  • Biomaterials Issues (Biomaterials Access Assurance Act)
HPM lawyers are involved a wide range of medical device product areas including, for example, heart valves, excimer lasers, medical imaging devices, orthopedic implants, defibrillators, medical software, and in vitro diagnostics.

Compliance and Post-Marketing Requirements

HPM has extensive experience in issues related to FDA regulation of marketed devices, including:
  • Establishment Registration and Product Listing

  • Quality System Regulation (QSR)

  • Medical Device Reporting

  • Device Modifications

  • Supplemental Applications

  • Corrections and Removals

  • Product Recalls
To view other enforcement matters frequently handled by our attorneys, click on Enforcement.


Primary Contacts:

Jeffrey Gibbs

Jeffrey Shapiro

Robert Dormer

Roger Thies




Firm Publications