Tracking COVID-19 Impact on Medical Device Reviews

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Latest Analysis

Data as of 12/31/2020

Review of some new Q-subs appear to be suspended.    Reviews of some 510(k)s have been delayed because available resources have been redirected to address the COVID-19 public health emergency.
It was inevitable.  The strain placed on CDRH resources has been steadily increasing over the past year.  As the number of pre-EUA and EUA submissions increased, more resources were shifted from the "normal, non-COVID" activities.  Review times and the number of "normal" submission do not appear to have suffered in 2020 (see the numbers below).  However, now we see the effects to Pre-submission requests (a.k.a., Q-subs) and delays in IVD 510(k)s.  
 
The message below was received after the January 19th acknowledgement message for a pre-submission meeting request.  At this time, our understanding is that this decision is being made on a Division by Division basis.  This message came from DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors.
Out on the RAPS Regulatory Exchange, others have reported similar delays in other groups:.
  1. OHT4 Surgical and Infection Control Devices,
  2. OHT5 Neurological and Physical Medicine Devices, and
  3. OHT7 In Vitro Diagnostics and Radiological Health.
Q-sub Notification Letter Redacted_Page_
Q-sub Notification Letter Redacted_Page_
510ks All by Month 2020.png

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.

510ks Weekly Review YOY 2020.png
510ks Trad  by Month 2020.png
510ks Spec  by Month 2020.png

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 a 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.

510ks All Review Days by Cmte & Month 20
510ks All Num by Cmte & Month 2020.png

Premarket Applications

The number of original PMAs is consistent over the past two years.  As is typical with the review times for original PMAs, there is a significant variability in the total review times. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Premarket Application Supplements

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. 

PMAS Number YOY 2020.png
PMA Original  Number YOY.png

The number of original PMAs is consistent over the past two years.  As is typical with the review times for original PMAs, there is a significant variability in the total review times. 

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   bit from 2019, the lowest number of supplements approved since 2016.

PMA Original Monthly Review 2020.png
PMAS Monthly Review 2020.png

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.

PMAS Monthly  Review & Type.png
PMAS Monthly Num & Type 2020.png

We hope you find this helpful.

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

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