Has FDA recently rejected your medical device submission e-copy?

Has FDA recently rejected your medical device submission e-copy?

January 2013

If you’ve had your FDA medical device submission e-copy rejected recently by FDA, you’re probably not alone. When firms submit the mandatory e-copy of their medical device submissions, FDA now requires the e-copy to conform to a mind-boggling array of specifications. Here are links to FDA’s corresponding Federal Register announcement and guidance document.

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