Tracking COVID-19 Impact on Medical Device Reviews

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Latest Analysis

Data as of 5/25/2020

Extraordinary times.  Many FDA resources are focused on the COVID-19 pandemic. 
Will it have an effect on review times?  We will investigate and post here every week.

Premarket Notifications [510(k)s]


For all types of 510(k)s, review times are trending downward so far this year.

The number of 510(k)s cleared is also holding steady this year and year over year.

We see the same trends when looking at either Traditional or Special 510(k)s.  Steady numbers cleared and a trend downward for average review times (see below).

However, prior years saw no downward trend in review times.

Are there more Specials being cleared? Doesn't look like it right now. 

Will watch this to see if the mix of 510(k) types change over time.

Given the needs of the COVID-19 response, it is reasonable to expect that some review groups are more affected than others.  The charts below break out the average review days and number cleared by reviewing group.

Difficult to say which ones have a definite trend so far, as there are small numbers in some groups.

There appears to be an increasing number of 510(k)s cleared in the General Hospital, General & Plastic Surgery, and Radiology while review times are holding steady.

Premarket Applications

For PMA Supplements, there is a slight downward trend for average review time.  A  56% drop in the number of approvals last week.  Have seen these drops before.  Will wait to see what happens this week. 

While this is the same general trend in average review times over the past three years, the total number of supplement approvals year over year is down about 11% from 2019, the lowest number of supplements approved since 2013.

There are many types of PMA supplements.  Each has their own review cycle.  

The graphs below break out the review days and the number approved by type of supplement.

We hope you find this helpful.

Let us know if you want to see a different analysis.  

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