The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
Stenzel reiterated he will accept direct contact from test developers who have not been assigned an FDA contact within two weeks of inquiring with the agency regarding a pre-emergency use authorization (EUA) submission for the COVID-19 pandemic. He had previously noted that FDA staff are swamped by the tasks imposed by the pandemic, including the interest in the EUA program from commercial developers and public and academic labs.
Stenzel said the agency’s staff has focused considerable effort on pre-EUA interactions with industry, but he urged test developers to go through the templates for the related test type prior to contacting the agency. This will allow the agency’s staff to focus on providing developers with additional guidance that is not included in the templates, which will economize the FDA’s time and energy.
“We want to review priority submissions on a rolling basis,” for applications directed toward any of the FDA’s priority areas, Stenzel said. The emphasis in this context is on developmental projects that have at least some body of data behind them, and the priority areas for the agency include point-of-care and high-throughput, automated test systems. The agency is also keen on seeing applications for home sample collection and home testing kits, Stenzel said.
The FDA staff may have difficulty processing an EUA filing if the sponsor does not promptly provide the information requested by agency staff, Stenzel said, requesting that sponsors provide that information as quickly as possible. He noted that the National Cancer Institute serological test validation system has posted more than 20 test validation results, and emphasized the need for developers to track updates to the templates for testing. Given the near constant stream of updates, FDA staff will assist developers in determining which of those updates are applicable to the developer’s test.
Stenzel reminded attendees on the June 24 town hall that test developers should include data from each sample for validation studies of serology tests, including the elapsed time between date of onset of symptoms and date of specimen collection. Antibody isotype results should be reported separately where applicable.
Testing emphasized in MDIC town hall
The Medical Device Innovation Consortium (MDIC) held an online town hall in lieu of its annual in-person meeting, and the range of topics spanned cybersecurity and patient engagement. Diagnostics and the COVID-19 pandemic were also on tap, as Sara Brenner, associate director for medical affairs at the Center for Devices and Radiological Health (CDRH) emphasized the role of data in the pandemic.
Brenner said, “we are seeing a lot of emergency use authorization (EUA) applications” related to testing and other considerations, adding, “we’re moving applications very quickly” while balancing the risks associated with rapid deployment of tests. The FDA’s emphasis is on both safety and innovation, but Brenner noted that testing is part of a larger strategy that includes more prosaic risk mitigation practices, including social distancing.
The FDA has teamed up with the Reagan-Udall Foundation and the Friends of Cancer Research on a COVID-19 evidence accelerator intended to address knowledge gaps in the response to the pandemic. Brenner said this effort will make use of real-world data, including data drawn from electronic health records, to “better develop use strategies for different diagnostics in different situations.” This and other programs are intended to track test performance, but Brenner pointed out that these responses to the pandemic require a vigorous data infrastructure, one of the targets of the MDIC collaboration between the FDA and industry.
CDRH director Jeff Shuren said more than 100 FDA staff have been involved in the MDIC’s programs, adding that COVID-19 is the top priority at CDRH. The center had issued 22 guidance documents related to the pandemic by the end of May, and more than 250 products have been authorized under the EAU program. Still, product shortages have also been a concern, and to that end, the agency has engaged with suppliers in more than a dozen nations to maintain some awareness of potential shortages. Shuren said the FDA has also worked to identify alternative sources of products, such as extraction reagents, swabs, and non-traditional components for ventilators.
Shuren said roughly 1,500 COVID-related EUA applications of various types have been received at CDRH to date, adding, “I’m so proud to see our staff rise to the challenge.” Since March, CDRH has received more than 200,000 calls and emails in connection with EUAs, and FDA staff have responded to 95% of those contacts. Shuren said, however, “we will only be successful if we work together through true partnerships, such as MDIC.”
Michelle Tarver, the CDRH patient engagement director, said patient engagement is critical to ensure device makers are generating solutions that are important to patients. FDA staff are working on a paper regarding maximizing patient input for design of clinical trials, but there are also plans for a patient engagement forum for communicating study results back to patients.
Some of the patient engagement efforts can shed light on patient valuation of specific outcomes, Tarver said, adding that the CDRH patient engagement advisory committee is the only one of its kind at the FDA. There are 20 industry-sponsored submissions that include patient-generated information that have helped modify study designs and labeling, and she said industry clearly sees a benefit in these engagements. Tarver said also that patient-generated health data, such as data drawn from wearables, and patient-driven registries will help create data for patient science that will be used to aid in evaluation of medical devices. The FDA also has plans to use social media to pick up on novel outcomes and adverse events in connection with medical devices, she said.