From creating product codes to following regulations, do you ever wonder what goes on inside the U.S. Food and Drug Administration (FDA)? In this episode, Allison Komiyama of Acknowledge Regulatory Strategies is a former FDA reviewer and she shares with listeners some fun facts about the FDA and what we don’t see behind closed doors. Some of the highlights of the show include: ● Fun Fact #1: FDA employees are not all about rules and red tape. They’re passionate about public health and do things creatively that benefit patients. ● Fun Fact #2: FDA is holder and keeper of Code of Federal Regulations (CFR) product codes. FDA has the ability to add or remove product codes. ● Fun Fact #3: Breakthrough Devices designation protects and promotes public health via access to timely development, assessment, and review of devices. ● Fun Fact #4: Opioid epidemic and pediatric care are two categories generating the most interest and activity regarding need for/availability of medical devices.