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FDA Floats Updated Guidance On User-Fee Refund Rules

This article was originally published in The Gray Sheet

Executive Summary

User fees paid to FDA by device firms for 30-day notices are not eligible for refunds if a company withdraws the submission, according to a March 13 draft 1guidance

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Regulatory News In Brief

FDA issues guidance documents on PMA and 510(k) user fees and refunds. Agency issues proposed order for three pre-amendment devices. More regulatory news.

Regulatory News In Brief

510(k) user fee guidance: FDA will no longer refund 510(k) user fees paid for products that are later determined not to be a device or to be exempt from 510(k) review, according to Aug. 27 1guidance on 510(k) user fees and refunds. The prior 2004 guidance said FDA would refund fees in such instances. The new guidance says it is the company's responsibility to review the regulations and determine whether a product is a device and whether it is 510(k)-exempt. FDA will only refund user fees mistakenly paid for the following 510(k) submissions that are statutorily exempt from the fee: submissions reviewed and submitted by FDA-accredited third parties, submissions for devices intended solely for pediatric patients, and submissions by state or federal government entities with no intent to commercialize. FDA updated its user fee guidance for PMA devices in March (2"The Gray Sheet" March 23, 2009)

Regulatory News In Brief

510(k) user fee guidance: FDA will no longer refund 510(k) user fees paid for products that are later determined not to be a device or to be exempt from 510(k) review, according to Aug. 27 1guidance on 510(k) user fees and refunds. The prior 2004 guidance said FDA would refund fees in such instances. The new guidance says it is the company's responsibility to review the regulations and determine whether a product is a device and whether it is 510(k)-exempt. FDA will only refund user fees mistakenly paid for the following 510(k) submissions that are statutorily exempt from the fee: submissions reviewed and submitted by FDA-accredited third parties, submissions for devices intended solely for pediatric patients, and submissions by state or federal government entities with no intent to commercialize. FDA updated its user fee guidance for PMA devices in March (2"The Gray Sheet" March 23, 2009)

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