FDA's Refuse to Accept Policy-510k submissions - 0 views
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Online Compliance on 20 Nov 14The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.