MEDICAL DEVICES & COMBINATION PRODUCTS

Greenleaf’s Medical Device and Combination Products Team guides clients through the complete regulatory process, from the earliest stages of product development, through the FDA review process, to marketing authorization and compliance with postmarket requirements and quality systems. Greenleaf applies extensive regulatory expertise to determine the best regulatory approach for a product and develop a comprehensive strategy to achieve a successful result. 

Additionally, Greenleaf’s deep bench of FDA experts advises litigators representing FDA-regulated clients and provides authoritative, objective expert opinions in disputes involving regulatory issues, including complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, and securities class actions.

Experts from Greenleaf’s Medical Device and Combination Products Team also provide advisory services that include extensive research and due diligence for investors engaged in potential deals that require regulatory risk analyses before and after decisions and transactions.

Learn more about Greenleafs Medical Devices & Combination Products Services:

Download Medical Devices & Combination Products Info Sheet

Download Medical Devices & Combination Products Capabilities Deck

Greenleaf’s Medical Device Services

Unmatched Regulatory Experience

Strategic consultation on:

  • FDA’s regulatory policies, programs, and procedures
  • Product development
  • Premarket review
  • Postmarket safety requirements
  • Market analysis for potential competition

Premarket Review Process

Experienced direction on:

  • Scientific and regulatory strategies for clinical programs and regulatory submissions
  • Recommendations and preparation for FDA meetings, including medical device advisory panel meetings
  • FDA communications, including formal, in-person, and regulatory correspondence

Regulatory Policy Guidance

Specialized insight on:

  • FDA policies and procedures
  • User fee requirements
  • Medical device advisory panel decisions and meeting preparation
  • Implementation of new FDA legislation, regulations, guidance documents, and FDA standard operating procedures

Marketing & Promotional Practices

Skilled support on:

  • Labeling requirements
  • Promotional materials
  • Direct-to-consumer advertising review processes
  • Remediation of untitled and warning letters
  • Use of social media

Litigation Support

Credible opinions via:

  • FDA institutional and regulatory knowledge-sharing
  • Expert declarations
  • Expert reports
  • Deposition testimony
  • Trial testimony

Download Litigation Support Info Sheet

Devices Team Members