Covid Led to Multiple Work Delays: CDRH
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say the Covid-19 pandemic has caused “unprecedented workload demands” on Center staff and resulted in delays in the Center’s “conventional” workload, including some tasks covered by MDUFA time commitments. Writing in an online post, Shuren and Maisel say the Center authorized a record number of novel medical devices in 2020 and issued 10-fold more emergency use authorizations (EUA) during Covid-19 than in all previous public health emergencies combined. “However,” they write, “this means that we are also prioritizing and triaging our work using existing resources to focus on our Covid-19 response, resulting in delays in some other work areas.”
In 2020, the post says, CDRH received over 17,000 premarket submission files of various types plus over 5,500 pre-EUA and EUA submissions, resulting in an overall increase in premarket submissions of 38%.
“Not surprisingly,” Shuren and Maisel say, “this unprecedented workload began to significantly strain Center resources as we continued to prioritize Covid-19 work, particularly in the review of in vitro diagnostic (IVD) files. This is the office within CDRH that has been impacted the most from the beginning of the pandemic due to the astounding number of pre-EUA and EUA submissions received for Covid-19 tests and collection kits. The divisions in charge of reviewing premarket submissions for ventilators and other respiratory support devices, as well as personal protective equipment (PPE), were also hit hard.”
The post describes the steps Shuren and Maisel say the Center has taken to address the large increase in work volume while attending to the great number of Covid-19 submissions. They say this included adopting “agile, interactive, and innovative approaches to EUA review” such as publishing 13 EUA templates that have been revised 11 times to clarify agency expectations and streamline review. CDRH also has issued 28 guidances that have been revised 17 times outlining policies to help expand the availability of medical devices needed in response to Covid-19.
The post says the biggest review challenges have been in the in vitro diagnostic area due to the volume of EUA submissions. “Unless IVD pre-submissions are related to Covid-19, a companion diagnostic, a breakthrough designation request, or have a significant public health impact, we have been unable to review them,” it says. “We have tried to utilize all the tools at our disposal. However, for the remainder of this year, we will be declining other IVD pre-submission requests that don’t fall into these categories for the present time. In addition, non-Covid-19 IVD submissions are experiencing longer-than-typical review timelines and delays in initiation of review. We anticipate eliminating review initiation delays on non-Covid IVD files within the next eight weeks, and will be providing sponsors with the name and contact information for their lead reviewer and projected review timelines within 30 days of submission receipt. While we’ve never had to take such actions in prior public health emergencies, we’ve also never experienced a pandemic like this one.”
The post says CDRH also has had a significant increase in workload for divisions reviewing files for PPE although they have been able to continue meeting MDUFA timelines for most marketing submissions. There are longer review times for pre-submissions now, it says, and the Center expects pre-submissions in those divisions to be completed within 120 days rather than the usual 70 days. “Premarket submission reviews and pre-submissions in other product areas are generally continuing under typical timelines although a small number of submissions may experience delays on a case-by-case basis,” it concludes.