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.
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
Maria Fontanazza has more than 15 years of experience in journalism, marketing and communications. She was previously marketing communications manager and market research manager at Secant Medical, Inc., a manufacturer of biomedical textiles and advanced biomaterials. Fontanazza also served as an editor at MD+DI and has authored articles that have appeared in domestic and international industry publications. Fontanazza has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT. Follow her industry insights on Twitter at @MariaFontanazza. Contact Maria