At Convergence, CDRH details its pandemic response

Regulatory NewsRegulatory News | 16 September 2020 |  By 

As the coronavirus pandemic swept through major US cities in the spring of 2020, the US Food and Drug Administration took unprecedented steps to address shortages and bring tests and potential therapies online with alacrity.
One center at FDA, the Center for Diagnostic and Radiological Health (CDRH), was faced with deciding how to address the potential for dire shortages of medical devices, while considering how to address such unconventional solutions as 3D printing of ventilator components and test swabs.
Speaking at RAPS Convergence 2020, which was held virtually, Angela Krueger, CDRH’s deputy director for regulatory policy, walked attendees through the hurdles CDRH has faced and the steps they’ve taken to adjust their emergency use authorization (EUA) process in response to the COVID-19 pandemic.
CDRH has exhibited unprecedented flexibility during the pandemic, said Krueger. “For example, we’ve worked with manufacturers to authorize novel products that we’ve never seen before for the public health emergency, including ventilation splitters and decontamination systems respirators.”
The number of EUAs that CDRH had issued for all previous public health emergencies totaled 56. For the COVID-19 public health emergency, CDRH issued 146 EUAs for SARS-CoV-2 molecular tests alone as of July 2020, she said, and over 200 diagnostic EUAs in all. Ventilators, including accessories, come next at 98; 75 EUAs have been issued for personal protective equipment (PPE). Serology and antigen tests, as well as PPE and PPE decontamination-related devices have also received numerous EUAs; emergency authorizations have been issued for about 20 categories of devices during the pandemic.
The device arm of FDA also has engaged with manufacturers in industries that have never before dealt with health agencies, she said. Among the industries “who haven’t been in the medical device space before” are auto and airline manufacturers, who have worked to supply PPE and ventilators. The use of 3D printers, she said, was a novel manufacturing method for swabs and ventilator parts.
CDRH has also implemented a number of novel policies and approaches, such as umbrella EUAs and new enforcement policies, in its response to the pandemic, said Krueger. In all, 23 guidance documents have been issued from CDRH since the public health emergency began.
To address shortages, CDRH has ongoing outreach to over 1,000 manufacturing sites in a dozen countries to be on the lookout for supply chain vulnerabilities. The agency also engages in “horizon scanning,” said Krueger, to assess demand for devices that will be needed to treat COVID-19 patients, and has been working to address import issues. The agency has also found alternatives to some diagnostic supplies that were in shortage, she said.
“We’ve also participated in implementation of Section 506J of the Food, Drug & Cosmetic Act,” requiring manufacturers of some medical devices to notify FDA of interruptions or discontinuance of manufacturing those devices, said Krueger. CDRH issued a clarifying guidance and accompanying webpage to guide manufacturers about their obligations for Section 506J notification during the pandemic, she added.
As CDRH built out its framework to speed medical device development during the pandemic, they added frequent webinars and town halls for manufacturers and marketers of gloves, gowns, testing equipment and other necessities for healthcare providers during the pandemic. They also adjusted how they communicated with stakeholders, building a call center and moving some calls to centralized mailboxes while implementing an effective triage system.
“CDRH has also developed a number of innovative approaches for our EUA review work,” said Krueger. “We have developed interactive real-time review templates that are available online and allow a sponsor to submit information to FDA and the team to interact with the sponsor to support a specific EUA for a specific product.” Templates are available for molecular, antigen and serology COVID-19 tests for both commercial manufacturers and laboratories, as well as for ventilators and surgical masks.

RAPS 2020 Convergence


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Tags: coronavirus, FDA, US

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