The United States Food and Drug Administration (FDA) is responsible for ensuring that medical devices that enter the U.S. market are safe and effective prior to distribution. The FDA has set high standards to ensure that their mission to protect the health and safety of U.S. consumers is properly met. Device manufacturers seeking/or currently distributing medical devices in the U.S. will benefit from this training.
The following critical steps to product and quality system compliance will be covered:
- Proper classification of medical device products based on the processes and systems used by the U.S. FDA;
- Education on best practices for interacting with the FDA to ensure proper alignment prior to the FDA submission process;
- The FDA product submission success and what to expect during FDA review;
- Explanation of the post-submission requirements, including overview of the quality system regulations (QSR);
- FDA inspectional preparation, including what to expect prior, during, and after a FDA inspection. Additionally, an overview of the FDA regulatory actions will be covered in detail, including the proper actions to be taken by device manufacturers in the event that inspectional observations are issued during an inspection.