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Regulatory News In Brief

FDA's device center issues a significant draft guidance on the 510(k) program, plus a draft on appeals processes open to sponsors. More end-of-the-year regulatory developments.

Companies planning to submit a 510(k) anytime in the future have some reading to do. On Dec. 27, FDA issued a hotly anticipated draft guidance to replace the aging documents that have long defined the pathway by which most devices reach the U.S. market.

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