MEDICAL DEVICE PRODUCT SUBMISSION SERVICES

The firm’s Medical Devices and Combination Products Team offers strategic and technical guidance on all aspects of the medical device submissions process, including the preparation of 510(k) and PMA submissions, 513(g) requests, de novo petitions, HUD, HDE and IDE applications, pre-submissions, and requests for designation of a combination product.

In addition to submission services, Greenleaf’s team of experts guides clients throughout a product’s lifecycle, including early stage development and postmarket requirements.

Greenleaf’s experts leverage their extensive regulatory expertise to determine the best regulatory approach for a product, develop a comprehensive strategy to achieve a successful result and assist the company in implementing the strategy.

Greenleaf’s Medical Device Product Submission Services

Premarket Preparation

  • Combination product designations
  • Requests for device classification (513(g))
  • Presubmission strategy
  • Identification of predicate devices
  • Determination of and compliance with performance data and labeling requirements
  • Demonstration of substantial equivalence/safety and effectiveness

Premarket Submissions

  • 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
  • Request for designation (RFD) of devices

Premarket Review Process

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

Marketing & Promotional Practices

  • Strategic guidance on labeling requirements
  • Promotional materials
  • Direct-to-consumer advertising review process
  • Remediation of untitled and warning letters
  • Use of social media
Download Submission Services PDF

Submissions Team Members