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codaras

08/01/17 11:12 PM

#6740 RE: ap #6739

The way I read it you are right.

Acceptance Review

After the Acknowledgement Letter is sent, the DCC routes the 510(k) to the appropriate ODE or OIR Division, based on the device type and medical specialty that is listed in the 510(k) submission.

Upon receipt in the Division, the 510(k) is assigned to the appropriate Branch, and then assigned to a Lead Reviewer. The Lead Reviewer conducts the Acceptance Review using the appropriate Acceptance Checklist in FDA’s Guidance titled Refuse to Accept Policy for 510(k)s. In the Acceptance Review, the Lead Reviewer determines whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.

Within 15 days of the receipt of the submission, the submitter will receive an electronic notification of the Acceptance Review result, which will:

smooch

08/02/17 12:07 AM

#6741 RE: ap #6739

If it is business days- Monday the 7 th...,