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Medical Devices - Regulatory Performance

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Review Times At a Glance

510(k) Premarket Notifications

2017

2018

Percentage of Cleared 510(k)s Based on Year Submitted

Data as of 1 Oct 2019

 

In general, review times across all types are fairly stable for the previous 2 years.

Approximately 80% of 510(k)s submitted in 2017 were successfully cleared.  

Expect the % of cleared 510(k)s filed in 2018 to increase as time goes by and more are cleared.

510(k) Review Time by Review Committee

All 510(k) Types

What Review Committee?  

Review times can vary based on the Review Committee.

In both 2017 and 2018, Anesthesiology and Molecular Genetics groups had the highest review times.  Radiology, Microbiology, and Ophthalmology had the shortest review times.

510(k) Review Time by Various Subsets

All 510(k) Types

How does having clinical data in a 510(k) affect review times?  What about combination products?

As it turns out, not much difference in review times.

And yes, there are Special 510(k)s that included clinical data.  

De Novo Reviews

Review Times At a Glance

De Novo reviews are generally longer than 510(k)s.  Over time, the review times have decreased, but the average is still closer to what we see with original PMAs.

Most are submitted directly, although there are still a few that are Post-NSE.

Less than half of De Novo submissions logged in are eventually approved.  The longer review times mean that we wait longer to really see the success rate.

2016

2017

2018

Percentage of Approved De Novo Based on Year Submitted

Data as of 1 October 2019

De Novo Review Times

by Reviewing Committee

Review times for De Novo submissions can vary greatly between reviewing committees.  

Note that in 2018, one outlier (DEN070001) in MI, drives their average higher.  Without the outlier, MI had an average review time in 2018 of 207 days.

 
 

Review Times At a Glance

Premarket Approvals

2016

2017

2018

Percentage of Approved Original PMAs Based on Year Submitted

Data as of 1 October 2019

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 supplement types have stayed fairly consistent year over year.

Original PMA Review Times by Advisory Committee 2017 to 2019 YTD

Review times increased for CV, SU, and OR in 2018.  Reviews in CH, TX and GU were higher than the 2017 average, raising the overall average review time 111 days.

De Novo Review Days Distribution

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Reasons for PMA Supplements

Process changes are the most frequent reason for a PMA supplement, followed by a design change.

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