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MedTech Summit
10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Jeff Shapiro
Partner at King & Spalding


Jeff has 30 years’ experience in US medical device law and regulation. He counsels firms in regulatory strategy and filings, including presubmissions, clearances, approvals, and breakthrough designations. He helps European firms, among others, to develop a sound regulatory strategy for bringing their medical devices through US FDA review, to draft the relevant submissions, and to respond to FDA’s requests for information and data. When advising start-ups and mid-sized manufacturers, Jeffrey recognizes the business considerations involved in creating regulatory strategies and managing compliance. His mission is to bring companies through the FDA process as efficiently and expeditiously as possible. Jeffrey also counsels companies on post-market compliance, such as reporting to FDA, complying with the quality system regulation, labeling and advertising compliance, recalls, inspections, and warning letters, and he is an expert in FDA’s regulation of combination products (e.g., drug-device combinations).

Agenda Sessions

  • Chairperson’s Opening Remarks: Regulatory Affairs in Global Markets: US Region

  • Overview of US FDA Regulation of Medical Devices

  • Primary Routes to US Market

  • A Closer Look at Premarket Notifications and De Novo Requests

  • A Closer Look at Premarket Approval (PMA) Applications

  • Making The Most of Q-Submissions

  • General Postmarket Requirements

  • Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets: US Region