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Kristin Davenport advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters, and import/export issues.

She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls, and Part 806 reports.

  • Represented device manufacturers in administrative appeals of PMA denials and not substantially equivalent (NSE) determinations.
  • Assisted start-up company in obtaining FDA feedback on regulatory status of its device through the 513(g) process.
  • Assisted device company with obtaining de novo risk-based classification.
  • Prepared comments on proposed regulations and draft guidance documents for trade organization and device manufacturers.