FDA Removes Emergency Use Authorization for 47 Chinese Respirator Manufacturers -How can they get it back?
Late last week, FDA removed approximately 47 firms from the list of those that are authorized to import and distribute non-NIOSH-approved respirators manufactured in China. This action was taken after government testing of samples produced by a few manufacturers produced results that did not meet the expected performance standards. As a result, FDA revised and reissued the Emergency Use Authorization (EUA) to remove all of the firms that were authorized under the April 3, 2020 EUA based on the independent lab test criterion for eligibility; even if their respirators performed to specification.
Pursuant to the revised EUA for non-NIOSH-approved respirators manufactured in China issued on May 7, firms that were removed from the authorized list as a result of this action can get back on the list if their respirators are tested by NIOSH and demonstrate adequate particulate filtration efficiency by June 21. There are, however, some issues with the implementation of this process.
First, NIOSH’s respirator assessment program to support the COVID-19 response is “not to be used by manufacturers, distributers, suppliers, or importers attempting to sell products in the United States.” Therefore, an affected manufacturer cannot be a good corporate citizen and reach out to NIOSH directly to comply with FDA’s testing requirement and do so within the allocated time. Instead, we have been informed that FDA must acquire and provide samples to NIOSH for testing.
The process for coordinating with FDA to provide samples has not yet been made clear. We have been reliably informed that, when FDA published the revised EUA containing this requirement, it had not established a mechanism for coordinating with affected manufacturers to collect samples for testing. In view of the 45-day deadline for completing this process, this apparent oversight has the potential to undermine the affected manufacturers’ ability to comply with FDA’s requirements. We are hopeful that FDA will soon issue guidance on this point.
In the absence of any guidance from the agency, we have learned that action to implement a sample collection and testing procedure is finally underway at FDA nearly a week after the requirement was imposed … well, at least the collection part of the process. Affected manufactures can reach out to FDA at CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov to coordinate with FDA to provide samples to the agency for testing.
Manufacturers that do so should be prepared to provide FDA with information about their respirator, where the respirators are located, and entry numbers, among other things. In addition, firms will be required to provide documentation proving that they are the true manufacturer of their respirators and will be required to also provide a signed statement certifying that they take responsibility for the accuracy and completeness of the information they previously provided as part of their EUA request.
We praise CDRH for putting together a plan for sampling in such short time and hope that they are also successful when coordinating with NIOSH to get the required testing completed within the allocated timeframe. Only time will tell.
About the author: Evan Phelps has specialized his practice in FDA and Medical Device law for the past 20 years and has been assisting members of industry with matters related to the COVID-19 pandemic since the beginning of the crisis.