MEDICAL DEVICES & COMBINATION PRODUCTS

Greenleaf’s Medical Device and Combination Products Team guides clients through the complete product lifecycle, from the earliest stages of product development, through the FDA review process, to marketing authorization, 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, tax litigation, 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 mergers and acquisitions that require regulatory risk analyses before and after decisions and transactions.

Greenleaf’s Medical Device Services

Product Lifecycle Management

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
  • 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 Device Services PDF

Devices Team Members