Monthly Archives: February 2017

Abbreviated 510k for your submission or a traditional 510(k)?

fdaecopy/ February 7, 2017/ Submission Type/ 0 comments

Article explains how to decide if you can use an abbreviated 510k submission to save 30 days of review time instead of a 90-day traditional 510(k). Last month (i.e., January 2017), there were only 9 abbreviated 510k submissions out of 222 510(k) submissions. The advantage of submitting an abbreviated 510k is that the FDA target for making a substantial equivalence

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