Edward M Basile (Ed)

Representative experience includes:

• Developed and implemented successful strategies for start-up and larger companies to obtain expedited marketing clearance and to resolve disagreements with FDA regarding deficiencies in premarket approval applications and premarket notifications.
  
  
• Represented companies in qui tam actions involving alleged violations of the FDC Act. Conducted internal investigations in connection with such actions.
  
  
• Represented companies in actions brought by state Attorney Generals involving alleged FDC Act violations.
  
  
• Represented companies and individuals in connection with Federal ciminal investigations of alleged FDC Act violations, including representation in connection with Grand Jury proceedings.
  
  
• Served as national FDA counsel for clients involved in the breast implant and pedicle screw mass tort litigation and represented these clients in a variety of related FDA product clearance and compliance issues.
  
  
• Assisted companies subject to FDA’s Application Integrity Policy, including conduct of independent internal audits of clinical studies, development of Corrective Action Programs, clinical SOP’s, and certification of data validity.
  
  
• Represented companies in meetings with FDA, including meetings with FDA District Offices, FDA’s Office of Device Evaluations, Office of Compliance, CDRH Center Director, and FDA Commissioner.
  
  
• Assisted groups of manufacturers in obtaining reclassification of medical devices such as automated differential cell counters, automated blood cell separators, and cardiopulmonary bypass pumps. Companies involved saved millions of dollars by avoiding PMA filings.
  
  
• Helped companies respond to FDA inspections, warning letters and criminal investigations, including investigations conducted by FDA’s Office of Criminal Investigations.
  
  
• Assisted companies in developing strategies for combination products, including preparation and filing of Requests for Designation.
  
  
• Assisted companies with regard to the regulatory status of tissue products that are subject to minimal processing.
  
  
• Represented Advanced Medical Technology Association (AdvaMed) in negotiations on the Safe Medical Devices Act of 1990, and representing companies before Congressional Committees including preparing testimony, responding to Congressional inquiries, and otherwise working with Congressional Committees.