FDA 510(k) reaction: The med-tech giant

The FDA’s announced rule changes for 510(k) medical device approval are a “good indicator that we’ll get to good decisions,” said the top regulatory official for Medtronic (MDT), the Minnesota-based medical device giant, in a phone interview on Wednesday.

“This announcement was extremely important to the industry, and it was very clear that they listened,” said Susan Alpert, senior vice president and chief regulatory officer. Alpert said she was relieved to see the FDA pass its most controversial recommendations, such as requiring companies to provide much more data for more devices, to an Institute of Medicine (IOM) committee for further review. “Originally the FDA indicated it was going to ask for a lot more information on almost everything,” Alpert said. “Now it’s clear in most cases they plan to get feedback before they go to final implementation.”

The FDA’s announced rule changes for 510(k) medical device approval are a “good indicator that we’ll get to good decisions,” said the top regulatory official for Medtronic (NYSE:MDT), the Minnesota-based medical device giant, in a phone interview on Wednesday.

“This announcement was extremely important to the industry, and it was very clear that they listened,” said Dr. Susan Alpert, senior vice president and chief regulatory officer. Alpert said she was relieved to see the FDA pass its most controversial recommendations, such as requiring companies to provide much more data for more devices, to an Institute of Medicine (IOM) committee for further review.

“Originally the FDA indicated it was going to ask for a lot more information on almost everything,” Alpert said. “Now it’s clear in most cases they plan to get feedback before they go to final implementation.”

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The majority of Medtronic’s revenue comes from products that require more stringent premarket (PMA) approval. But for those units that rely heavily on 510(k), which generally requires demonstration that a new device is substantially equivalent to another on the market, Alpert said she was glad to see the FDA following through on intentions to better train staff and provide more clarity. “There’s still concern about the detail to come, but this is very reassuring,” she said. “It’s much more balanced than the original recommendations.”