FDA Workshop

This workshop is included in your registration.

Friday, April 6th 2018, 6:00pm – 7:30pm.

The responsibilities of the Food and Drug Administration (FDA) have increased greatly since the inception of the Food and Drugs Act in 1906.  Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act.  However it was not until 1976, under the Medical Device Regulation Act, that the FDA became responsible for the safety and effectiveness of medical devices. The recently passed 21st Century Cures contains provisions clarifying medical software regulation, and FDA’s Center for Devices and Radiological Health has issued new guidance to communicate the implementation of this act.

This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA.  The symposium will discuss how we protect and promote public health with a focus on medical imaging applications. We will discuss three areas: pre-market device review; regulatory research efforts related to imaging hardware, and regulatory research efforts related to image analysis, computer-aided diagnosis, and quantitative imaging methods. We will also discuss mechanisms we use for partnering with other organizations and give examples.

The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of medical imaging devices in the US, highlighting resources available to assist investigators and manufacturers.  The research presentations will describe investigations that support the regulatory mission of the Agency.  The audience will get an overview of our regulatory research portfolio intended to advance our understanding of imaging technologies and approaches to their evaluation. Mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be described.

  1. Jessica Lamb: Premarket pathways and support for industry
  2. Andreu Badal: 1st of two presentations on research efforts and external partnerships
  3. Qin Li: 2nd presentation on research efforts and external partnerships