Senate OKs limits on fees to approve medical devices

The bill doesn't mean small manufacturers pay no application fee, says Cullimore. The smallest companies, up to $30 million, get their first PMA application free. After that, for those with sales up to $100 million, it's a reduced fee based on their size.

Perhaps as important, he says, the bill, which will have to be reauthorized in 2007, doesn't give Congress the option of not funding it.

Not everyone's convinced the bill does enough, though.

"I'm happy that some restriction was placed on the fees," said Kevin Cornwell, chairman and CEO of Utah Medical Products Inc. "The bloodletting has been substantial, and this sort of puts a Band-aid on it.

"My perspective is it's (the FDA) still way overfunded if you look at agency productivity."

Cornwell says the fee significantly overcompensates the FDA for its efforts in going over the applications. The approval of a 510k application shouldn't take more than a day or two, since it's mostly administrative and the technology or theory of the device is already vetted. And one PMA fee is enough to pay the approving scientist's entire salary for a year, although it certainly doesn't take one scientist a year to review a product. He thinks the fees are money-makers for the agency.

"At the end of the day, it's a tax on people who are trying to develop innovative products to improve our health care. And when you raise taxes, it discourages that," Cornell says.

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E-mail: lois@desnews.com