MEDICAL DEVICES & COMBINATION PRODUCTS

Greenleaf delivers services that assist clients from early stage development to marketing authorization and throughout a product’s lifecycle. The firm’s Medical Devices and Combination Products Team offers strategic and technical guidance in key areas, including FDA submissions, FDA’s review process and postmarket requirements such as safety monitoring and quality systems. Greenleaf makes this possible by applying extensive regulatory expertise, determining the best regulatory approach for a product and providing a comprehensive strategy to achieve a successful result.

Greenleaf assists clients with all aspects of the regulatory review process for medical devices and combination products. Greenleaf also assists with the medical device submission process, such as the preparation of 510(k)s and PMAs, 513(g) requests, de novo petitions and HUD, HDE and IDE applications.

Experts from Greenleaf’s Medical Devices and Combination Products Team also provide advisory services that include extensive research and due diligence to firms engaged in potential mergers and acquisitions that require a regulatory risk assessment before and after a life sciences transaction.

Greenleaf’s Medical Device Services

Product Lifecycle Management

  • Strategic guidance on FDA’s regulatory process
  • All aspects of product development
  • Premarket review
  • Postmarket safety requirements
  • Analysis of the market to identify potential competition

Premarket Submission Preparation

  • Request for classification information (513(g))
  • 510(k) premarket notifications
  • Premarket approval applications (PMAs)
  • Requests for de novo review of automatic Class III classification
  • Humanitarian use designation (HUD) / humanitarian device exemption (HDE) applications
  • Investigational device exemption (IDE) applications

Premarket Review Process

  • Scientific, medical and regulatory guidance for clinical programs and regulatory filings
  • Strategic guidance and preparation for FDA meetings, including medical device advisory panel meetings
  • Analysis of, and recommendations on, FDA communications

Marketing & Promotional Practices

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

Regulatory Policy Guidance

  • Analysis of FDA policies and processes
  • User fee requirements
  • Medical device advisory panel meeting analyses
  • Implementation of new FDA legislation, regulations, guidance documents and FDA standard operating procedures
Download Device Services PDF

Devices Team Members