FDA News: FDA Commissioner Nomination, Listing of Class II Exempt, Office of Patient Affairs – Drug and Device Digest

FDA BRIEF: Week of March 13, 2017


Dr. Dr. Scott Gottlieb nominated as next FDA Commissioner

  • Former FDA deputy commissioners for medical and scientific affairs from 2005 to 2007
  • Practicing physician and governmental health policy adviser
  • Resident fellow at American Enterprise Institute, Clinical Assistant Professor at New York University, Health Information Technology adviser for the Department of Health and Human Services
  • To be confirmed by the Senate
American Enterprise Institute

Class II.JPG

Class II devices that the FDA is proposing to exempt or partially exempt from the premarket notification [510(k)] requirements.

List of 1,003 class II devices that will be exempt or partially exempt from 510(k)

  • In accordance with streamlined procedures established by the 21st Century Cures Act
  • Identified devices are sufficiently well understood and do not present risks
  • No premarket notification review for reasonable assurance of safety and effectiveness

Not exempt from other regulatory controls

  • Suitable for the intended use
  • Adequately packaged and properly labeled
  • cGMP requirements for manufacture
  • Have establishment registration and device listing forms on FDA file



FDA Office of Patient Affairs

Office of Patient Affairs to enhance mechanisms for patient engagement 

  • Provide a more transparent, accessible, and robust experience for patient communities
  • Based on public feedback solicited per Food and Drug Administration Safety and Innovation Act (FDASIA)


  • Offering a single, central entry point to the Agency for the patient community
  • Providing triage and navigation services for inbound inquiries from patient stakeholders
  • Hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA’s relationships with patient communities
  • Developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels



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