Sen. Warren Hosts Meeting with MassMEDIC Delegation and Senior FDA Officials

Massachusetts Senator Elizabeth Warren convened an hour-long meeting with MassMEDIC representatives and FDA Commissioner Margaret Hamburg and CDRH Director Jeffrey Shuren on Friday, April 4.  At Senator Warren’s request, the MassMEDIC delegation developed a list of priority regulatory challenges faced by area MedTech companies for presentation at this meeting. These included: 

  • Balancing data requirements – pre-market vs. post-market
  • Use of Outside U.S. (OUS) Data in Product Submissions Alternative pathways for novel technologies
  • Guidance Documents – Clarification of the Use of “Drafts” and Retroactive Applications
  • Consistency of Review Training and Adequacy of Management Oversight

A summary of the meeting, including the specific actions recommended by MassMEDIC may be found here.

Among those presenting on behalf of MassMEDIC were:

  • Jacob Einhorn, Intrinsic Therapeutics
  • Tamima Itani, Boston Scientific
  • Sharon Starowicz, DePuy-Synthes
  • Pam Weagraff, Quintiles Consulting

A follow-up meeting with CDRH Director, Jeff Shuren, is planned for mid-June in Washington with Sen. Warren pledging to follow-up on agency progress on these issues.