FDA loosens rules on stair-climbing wheelchairs

The Food and Drug Administration (FDA) is relaxing the regulations on stair-climbing wheelchairs that carry elderly people up and down the steps in their homes, despite some safety concerns.

The FDA announced Friday that it will no longer require these devices to receive pre-market approval, because they do not pose as much of a risk to the public as previously thought.

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Instead, stair-climbing wheelchairs will face less stringent safety regulations that don't require pre-market approval. The FDA says these rules will still "mitigate the risks and provide reasonable assurance of safety and effectiveness for stair-climbing wheelchair devices."

"The (FDA advisory committee) found that stair-climbing wheelchairs are not life supporting or life sustaining," the agency plans to write in Monday's edition of the Federal Register.

This comes despite concerns from at least one patient advocacy group, which warned the FDA that easing the rules would endanger elderly people who rely on these devices to move around their homes.

"This change in classification would result in greater risk for some of our nation's most vulnerable consumers," the advocacy group wrote in a comment submitted to the FDA. 

The advocacy group, which the FDA did not name, cited the agency's own safety data, and pointed to risks that the FDA acknowledges these stair-climbing wheelchairs pose.

The FDA maintains that stair-climbing wheelchairs pose several risks, including instability that could result in the device tipping over or slipping off the edge of the staircase. The stair-climbing wheelchairs can also entrap users, so they can't get out, the FDA noted.

However, the FDA believes that the new less stringent regulations will still be adequate to prevent these problems, the agency noted.

The FDA is moving forward with the changes after it proposed the rule last June and held a meeting to discuss it in December.

The rule change goes into effect immediately.