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FDA Charges Ahead With MDUFA III Implementation, Despite Budget Uncertainties

FDA has started carrying out its end of the medical device user fee agreement, with plans to issue several new guidance documents this fall, and the agency suggests that a short-term restriction on full user fee access should not inhibit its efforts.

Fiscal year 2013 has started and FDA says it is moving full speed ahead with implementing policies from the medical device user fee agreement (MDUFA), despite restrictions on user fee spending. But how long the restrictions can last without impacting the program reforms remains uncertain, a top FDA official said last week.

The six-month continuing resolution passed by Congress in September funds FDA through March at fiscal 2012 levels plus a small update, and allows continued collection of user fees. But, while companies will be expected to pay increased fiscal 2013 user fee rates, the appropriations bill only allows FDA to spend the fees at 2012 levels. This would add up to an approximately $30 million user fee shortfall for the full fiscal year based on the 2013 rates negotiated with industry for the recently reauthorized MDUFA III program

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