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
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)
Responsibilities:
- 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