FDA Views: Work @ FDA, CDRH Anniversary – Drug and Device Digest

FDA BRIEF: Week of June 20, 2016


FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science


By: Robert M. Califf, M.D.,  Commissioner

  • FDA  commitment to using best available science to support mission to protect and promote public health
  • Scientific breakthroughs offer unprecedented opportunities  to develop new treatments and cures
  • Deep personal and professional satisfaction gained from working in FDA’s state-of-the-art laboratories on front-line issues

Being Part of a Vibrant Collaborative Scientific Environment

  •  FDA offers  opportunity to be  part of  vibrant, collaborative culture of regulatory science
  • Work is directly tied to regulatory decisions
  • Fellowship, internship, graduate, and faculty programs

Tackling the Most Challenging Scientific Issues

  • Encourages professionals collaborate with FDA on  transformative scientific issues
  • Need the best scientific minds to make science-based decisions on benefit/risk
  • Great  career opportunities at FDA


FDA Celebrates the 40th Anniversary of the Medical Device Amendments

Jeffrey Shuren, M.D., J.D.

by: Jeffrey Shuren, M.D., J.D.,  Director of CDRH

  • FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments
  • Congress gave FDA explicit authority over medical devices in the 1938- but focus only on fraudulent products
  • Safety disaster with ‘Dalkon Shield’ enacted Medical Device Amendments in 1976 for risk based classification and GMP compliance
  • Ushered in a new era for medical technology innovation, patient access, and patient safety – along with political tensions
  • CDRH has adapted expertise and regulatory approaches to meet rapidly evolving innovation
    • Digital Health regulatory framework
    • National Evaluation System (NEST)
    • Patient engagement


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