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Device Makers Agree to Double FDA Fees for Quicker Reviews

Medical device makers will double the fees they pay U.S. regulators to get products reviewed over the next five years, to $595 million, in a deal designed to secure faster and more predictable evaluations, the Food and Drug Administration said today.

The pact, which must be authorized by Congress, replaces one that cost Medtronic Inc., Johnson & Johnson and other device makers $287 million over the last five years and expires on Sept. 30. The agreement, which is still being finalized, would allow the FDA to hire 200 full-time employees by the end of the five-year program, the agency said in a statement.