Modest Device Material Change May Need New 510(k): Post

Even seemingly modest medical device material changes such as new colorants, a different preservative, or a reformulated component sourced from a new supplier, may require submission of a new 510(k) to FDA. That’s the advice from principal medical device regulation expert Adrienne Lentz (Hyman, Phelps & McNamara) in an online FDA Law Blog post.

Lentz reviews the agency guidance on deciding when to submit a 510(k) and what it considers to be a significant change.

“In practice,” she says, “many changes in device materials stem from supply chain changes or are implemented to make minor improvements to the product line. They are often minor variations in formulation that do not require a different type of biocompatibility test, and device manufacturers may be tempted to conclude that the biocompatibility risk is the same as that of the original device, even if they elect to repeat one or more biocompatibility tests that were also required for the original device.”

In the post, Lentz cites two recent Warning Letters in which FDA found that a change in polymers and colorants used in contact lens cases, and a change in the preservative in an ultrasound gel were each significant changes that warranted a new 510(k).

“Manufacturers evaluating such changes should document their risk analysis carefully against the factors in FDA’s change guidance, resist the temptation to equate repeat testing with equivalent risk, and, where any doubt remains about whether a change could significantly affect safety or effectiveness, consider a new 510(k) submission or engage with FDA before implementing the change,” she concludes.