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Regulatory News In Brief

FDA tells small businesses how to qualify for discounted user fees. Agency plans September conference for industry on unique device identification proposed rule. More regulatory news.

FDA released its FY 2013 small business qualification and certification guidance Aug. 1, explaining how firms can qualify for discounted user fees. It is substantially the same as the 2012 guidance, but includes updated information on the standard and small business user fees rates for 2013. Both domestic and foreign businesses can qualify as small businesses and pay discounted fees if they have reported gross sales of $100 million or less. If a company’s gross sales are $30 million or less, the firm can obtain a one-time user fee waiver for its first-ever PMA submission.

FDA also formally published in the Federal Register

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