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Compliance Updates
Warning Letters
Recalls
Inspections
Corporate Integrity Agreements
Orange Book additions
Guidance Documents - New
Guidance Documents - Withdrawn
UNDER CONSTRUCTION
New 510(k) Clearances
New De Novo Approvals
New PMA Approvals
Product Codes - New & Withdrawn
De Novo Review Days Distribution
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Review Times
510(k) Premarket Notifications
Review Times At a Glance
In 2019, Traditional and Special 510(k) review times remain steady in early 2019
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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).
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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.
Premarket Approvals
Review Times At a Glance
Average review days for original PMAs increased to 465 days in 2018 from 354 days in 2017.
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Panel Track Supplement review days also rose in 2018. The rest of the types of supplements stayed fairly consistent year over year.
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