Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “Modification Guide Could Up-Classify Devices in Combo Products, Lawyer Says.”
Following is an excerpt:
FDA’s proposed guidance on post-approval modifications for combination products approved under a single application, while narrow in scope, could spur an influx of supplemental submissions as changes to low-risk devices could require supplemental drug applications and fees, according to an attorney representing combination product manufacturers. FDA released the document alongside a long-awaited final good manufacturing practice rule for combination products late last week.
The guidance document applies to combination products approved under one application, including a biologics license application, new drug application or device premarket approval application. Most combination products are approved through dual applications, but for products subject to the document, the guidance could spur more supplemental drug applications for changes to low-risk devices, said Bradley Merrill Thompson, general counsel for the Combination Products Coalition. ?…
“It’s really up-regulating that device component and the change associated with it,” he said, noting that filing a supplemental NDA will result in higher user fees and more rigorous requirements to make the change.