Regulatory Focus™ > News Articles > 2021 > 10 > IT and staffing issues impeded CDRH pandemic test response: Report

Regulatory NewsRegulatory News
Posted 13 October 2021 | By Kari Oakes 

IT and staffing issues impeded CDRH pandemic test response: Report

2991 Lagging information technology infrastructure, inefficient staffing, and validation methods that were not set up for a pandemic were among the weaknesses identified by an outside assessment of the U.S. Food and Drug Administration’s (FDA's) handling of COVID-19 diagnostic test emergency use authorizations (EUAs) during the pandemic.
The independent report, conducted by the consulting firm Booz Allen Hamilton at the request of FDA's Center for Devices and Radiological Health (CDRH), was released by the agency today, along with responses from CDRH to key recommendations in the  independent evaluation.
“The FDA agrees with the priority recommendations identified by Booz Allen Hamilton in their independent assessment of our COVID-19 response. From the beginning of the pandemic, we have adapted our regulatory approach to address the public’s testing needs and worked actively with COVID-19 test developers to adjust our policies as those needs have changed or the science has evolved," said CDRH director Jeffrey Shuren in a statement that accompanied the report and FDA’s responses.
One of the key findings from the review of the EUA process was that the submission and tracking system for EUA requests was not fully automated, and could not provide sufficient review efficiency for the center. In response, FDA identified several steps that it has already taken since the beginning of the public health emergency of the pandemic to streamline submission tracking and other processes associated with EUAs.
CDRH also pointed out that it is in the middle of its digital transformation initiative, initiated in fiscal year 2016. “this effort will help CDRH better track future EUA requests as well as provide better platforms for interacting with medical device sponsors when questions arise about their submissions,” wrote the center.
Another key observation made by the Booz Allen Hamilton report is that a more systematic approach for allocation and tracking of staff should be prepared for future public health emergencies.
Here, CDRH again agreed. Concrete steps being taken by the center to “proactively prepare for future situations” involve having a blueprint ready for future emergencies that will accomplish the goal of having “the right people” engaged at “the right time” in the future. Plans are also underway to have surge capacity staffing and allocation ready, and to identify the triggers that would prompt FDA to move to surge capacity.
Other staffing accommodations include having qualified contractors on hand to be utilized when up staffing is required. Further, CDRH responded that some of the simplification and streamlining that it is putting in place with the EUA process will also help achieve personnel efficiency.
Some of the inefficiencies of the test validation process, according to the report, had to do with the “limited understanding” that test developers had for how diagnostic tests should be appropriately validated. Booz Allen Hamilton recommended that CDRH give some thought to how tests for emerging pathogens could be validated in the context of a future public health emergency.
In response, the center noted that it is planning to work alongside test developers to build templates for pathogen types “that may be adapted for potential future outbreaks.” Additionally, CDRH is building a framework for how validation testing could be done in a variety of circumstances, depending on the severity and urgency of the public health emergency.
However, this does not mean that CDRH is envisioning starting from scratch with test validation: “CDRH believes that common approaches to validating test design and performance can support development of accurate and reliable tests, regardless of whether there is an emergency,” responded the center.
The town halls and other communication formats that have worked during the COVID-19 pandemic are efforts CDRH plans to continue. FDA is also turning to the US government for assistance in ensuring that international partners be ready to share specimens at the first sign of a public health threat, since these clinical specimens are required for optimal test validation.
Also, CDRH is asking for capacity-building to achieve independent evaluation of test performance before an outbreak. “CDRH’s collaboration with the National Cancer Institute demonstrated the value of this approach,” wrote the center. The EUA pathway coupled with a robust federal evaluation process could speed the entry of molecular diagnostic, antigen and serology tests to market by minimizing the need for individual test developers to acquire specimens for their clinical validation efforts.
“We will continue to take a flexible approach to COVID-19 tests to meet public health needs and increase access to testing for consumers, including at-home diagnostic tests, which remain a top priority for the agency, that is grounded in sound science,” said Shuren.
Booz Allen Hamilton Report


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you