Monday, June 4; 9 AM – 10 AM
Presenters: Mac McKeen, Fellow, Boston Scientific
Tim Philips, FDA’s Office of Medical Device and Radiological Health Operations, Compliance Officer
This presentation will discuss the organization and operations of FDA’s Office of Regulatory Affairs (ORA) – the lead office for the agency’s field activities. By conducting inspections, analyzing samples, and enforcing FDA regulations, ORA protects consumers, enhances public health, and minimizes risk associated with regulated products. Important changes are taking place in the regulatory landscape with ORA’s recent reorganization (a.k.a. program alignment) and new initiatives such as device benefit-risk assessments and the Medical Device Single Audit Program (MDSAP). Learn how FDA field offices are blending tried-and-true practices and new programs to accomplish their mission.