Washington

The U.S. Food and Drug Administration is considering charging medical device makers a fee to review new products, an FDA spokeswoman told HomeCare.

“In recent weeks, the FDA has been talking to different parts of the medical devices industry about the possibility of developing a user-fee program,” she said. While there may be some exceptions, the fee generally would apply to every medical device that the FDA reviews under pre-market approval applications, or 510(k) notices — including home medical devices, she explained.

The idea is not new. More than a decade ago, Congress approved the Prescription Drug User Fee Act, which authorized the FDA to collect fees from pharmaceutical companies in exchange for reviewing new drugs. The agency used the resulting revenue to hire more reviewers, in an effort to speed the drug-approval process.

But a similar user-fee proposal for medical devices died in the planning stages, because certain medical-device industry representatives opposed the fees, the FDA spokeswoman continued.

Now the agency has resurrected the proposal, in the form of the Medical Device User Fee Act, or MEDUSA, which some in the medical-device industry already have endorsed.

“The goal is to try to do something during this session of Congress,” the FDA spokeswoman said.

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