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Compliance Updates

Warning Letters



Corporate Integrity Agreements

Orange Book additions

Guidance Documents - New

Guidance Documents - Withdrawn


New 510(k) Clearances

New De Novo Approvals

New PMA Approvals

Product Codes - New & Withdrawn

De Novo Review Days Distribution

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De Novo Review Time Distribution 17&18 B

Review Times

De Novo

510(k) Premarket Notifications

Review Times At a Glance

In 2019, Traditional and Special 510(k) review times remain steady in early 2019

Dual Track and Abbreviated average review days remain variable from month to month.  This is likey because these submissions are relatively few in number compared to the Traditional and Special 510(k).

510ks All  past 12 Months.png

De Novo Review Times

One De Novo approved in 2018 had a review time of 4,266 days (DEN070001).  If this outlier is not considered, the average review times for De Novo submissions in the past 12 months averaged 320 days.  

De Novo past 12 Months.png

Premarket Approvals

Review Times At a Glance

Average review days for original PMAs increased to 465 days in 2018 from 354 days in 2017.

Panel Track Supplement review days also rose in 2018.  The rest of the types of supplements stayed fairly consistent year over year.

PMA & Suppl Review Time 17&18 Grn.png
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