Tracking COVID-19 Impact on Medical Device Reviews

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Latest Analysis

Data as of 7/20/2020

FDA acknowledges the strain on review resources.  Many FDA resources are focused on the COVID-19 pandemic. 
Is it having an effect on review times?  Some trends are starting to show. We are monitoring and post here every week.
The number of 510(k)s cleared is trending down while review time remains steady.
PMA supplement review time spiked two weeks ago, turning the trend upward to longer times.  The number of supplements approved is starting to trend downward.

Premarket Notifications [510(k)s]

 

For all types of 510(k)s, review times are maintaining 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,  The  downward trend for average review times we have been seeing has leveled off.

 

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 decreasing number of 510(k)s cleared in the General Hospital and Orthopedic. Dental review times are trending up, while review times in most other groups are holding steady.

Premarket Applications

For PMA Supplements, there is an upward trend for average review time after a spike two weeks ago.  The number of approvals is trending downward.    Some variability is expected.  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 17% from 2019, the lowest number of supplements approved since 2016.

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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