FDA’s new Commissioner to review the agency’s medical device approval process

In a recent edition of the Medical Device Outsourcing Website, it stated that the new FDA Commissioner Margaret Hamburg recently told lawmakers that she wants to take a good look at the agency’s medical device division.

It stated that Ms. Hamburg would look into the division's 510(k) regulatory approval process for devices. There had been some concern by the agency’s scientists that some companies should have been required to show more data on safety and efficacy.

Former FDA Commissioner David Kessler, also through some fuel to the fire by describing the device center as “dysfunctional” and “in meltdown.”

The Medical Device Outsourcing stated that the Advanced Medical Technology Association (AdvaMed), the Washington lobbying group for the device industry based in Washington, D.C., doesn’t think the regulatory process needs fixing.

“The current system for medical device regulation is fundamentally sound and gives FDA the flexibility it needs,” said Janet Trunzo, an executive vice president at AdvaMed.

It will be interesting to see what the outcome of this review of the 510(k) process. From mdi’s experience with the 510(k) process, the FDA has been requesting more and more documentation and evidence on the safety and efficacy of the devices. For many devices the 510(k) process is almost similar to the PMA process, minus the pre-award inspection and the medical panel review. Making it more difficult to get a 510(k) clearance will put tremendous strain on the medical device industry and undo damage to the competitiveness of the industry and to the small businesses that have been using the 510(k) process to enter the marketplace.

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