When preparing for an inspection, it’s important to remember that you’re the expert of your combination product, according to Melanie Drayton, managing consultant at Navigant. “That means you need to be able to provide a big picture of your product, the statistics, data, and trends associated with product,” says Drayton. “The FDA investigator is not an expert on your product.”
Drayton spoke about the considerations of inspections specifically related to combination products during MedTech Intelligence’s Combination Products in June. While FDA investigators are trained to look at the big picture of the device within its lifecycle, they don’t necessarily understand all of the nuances of a combination product. It’s important to be proactive, says Drayton, and take the time to train the investigator to understand your product.
Learn more about what an FDA investigator is looking for during an inspection in the following video.