Discussion Topics at the Symposium

The 21st Century Cures Act—find out how the new regulation will accelerate pathways for product approval, provide clarification in regards to medical device software, establish a combination products/intercenter institute, and establish a new standards recognition process

Medical Device User Fee Agreement (MDUFA) IV—hear details on new proposed enhancements to the program that will look to advance patient input and involvement in the regulatory process; support the National Evaluation System for health Technology (NEST) and its use of real world evidence; streamline and align FDA review processes for Software as a Medical Device (SaMD) and software inside of medical devices (SiMD); establish an Accreditation Scheme for Conformity Assessment (ASCA) Program using FDA-recognized consensus standards; and further the 3rd party review program.

Key International Standards Initiatives—listen to standards experts discuss the role of standards in meeting compliance requirements as they relate to:

  • Quality
  • Risk management
  • Postmarket surveillance
  • Health and medical device software and IT systems
  • Cybersecurity

International Medical Device Regulators Forum (IMDRF) Activities —get the latest on the Forum’s work items on the Medical Device Single Audit Program (MDSAP) and improving the quality of international medical device standards for regulatory use.

EU Medical Device Regulation—learn as experts provide information on the status of the regulation, with focus on the new clinical data requirements, expanded obligations for IVD products, and the significant changes for economic operators (importers and distributors).