Tracking COVID-19 Impact on Medical Device Reviews
Data as of 9/28/2020
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. Review times overall are trending up.
PMA supplement review time spiked two weeks ago, turning the trend upward to longer times, buy has since dropped down. The number of supplements approved is also stabilizing. All in all, FDA is doing a fair job keeping to their review commitments. However, the reallocation of resources to handle the COVID-19 pandemic is having an effect.
Premarket Notifications [510(k)s]
For all types of 510(k)s, review times are increasing a bit since the first o the year.
The number of 510(k)s cleared is dropping slightly, but no major shifts 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 appears to be heading up.
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.
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.