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Home » 'Clerical errors' common trigger for rejected special 510(k)s
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'Clerical errors' common trigger for rejected special 510(k)s

Nov. 1, 2019
By Mark McCarty
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers.
BioWorld MedTech Regulatory 510(k)

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