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FDA Revises EUA Criteria for Respirators Manufactured in China

In a May 7 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its April 3 LoA with revised eligibility EUA criteria for non-NIOSH-approved disposable filtering facepiece respirators manufactured in China. As a result of the revision, Appendix A currently lists only 14 Chinese manufacturers (down from a peak number of approximately 80 manufacturers prior to this recent criteria change) that can supply authorized respirator models. FDA changed the eligibility criteria due to manufacturers’ products failing to demonstrate a minimum particulate filtration efficiency of 95 percent.

According to FDA’s current criteria, as outlined in the May 7 LoA, in order to be eligible for authorization under the EUA, a respirator must meet one of the following criteria:

  1. Respirator is manufactured by an entity that holds one or more NIOSH approvals for other models of respirators produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA.
  2. Respirator has a regulatory authorization under a jurisdiction, including the Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority, that can be authenticated and verified by FDA.
  3. Respirator was previously listed in Appendix A under the April 3 LoA as an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEBAPR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.

If a respirator meets one of the above current criteria, FDA will add the respirator to Appendix A as an authorized respirator once FDA confirms eligibility criteria are met. As noted, FDA has removed from Appendix A respirators that fail to meet the above criteria. FDA also states that it may remove respirators from Appendix A if FDA has reason to believe that the respirator is no longer eligible for authorization. Further, FDA will no longer allow importers to submit requests to add respirators to Appendix A.

Note that in the original third criterion in the April 3 LoA respirators eligible for authorization “demonstrate acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA.” The current criterion 3, as shown above, mandates NIOSH testing within 45 days of the EUA, with results indicating a minimum and maximum filtration efficiency greater than or equal to 95 percent.

For a full list of the requirements for authorized respirators, please see the full May 7 LoA.

Please note the revised May 7 LoA regarding non-NIOSH approved respirators made in China does not affect the previous March 28 LoA for Non-NIOSH-Approved Imported Respirators.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 132

TRENDING LEGAL ANALYSIS


About this Author

Gary Rom Health Care Lawyer Faegre Drinker
Associate

Gary Rom goes beyond rule-based counsel to help health care clients develop creative, compliant solutions to launch and promote drugs and medical devices and their corresponding support programs.

An agile advisor and former legal associate for Eli Lilly and Company, Gary is intimately aware of the interplay between how products are marketed and how that marketing impacts competitor complaints, consumer protection actions and product liability. He partners with clients to help them understand that balance and navigate it aptly, accounting for business objectives and regulatory...

317 569 4684
Counsel

Ted Lis entered the practice of law after nearly a decade as a chemical engineer for a major American chemical company, and is a senior member of the American Institute of Chemical Engineers. He uses his legal and engineering training to improve his clients’ standing with FDA and other regulatory agencies with respect to Good Manufacturing Practice (GMP) and Quality System (QS) regulation. Over the course of his career, Ted has assisted manufacturers in more than a dozen countries that produce API, aseptic injectables, biologics, combination products, ophthalmics, oral solid doses, medical devices and vaccines.

Working with industry and company experts, Ted applies his broad experience to advise Quality and Manufacturing managers who face critical issues that are the focus of regulators. He assists clients with managing communications with regulatory agencies, preparing for pending site inspections and training personnel. He also provides on-site support during inspections to assist subject-matter experts in cogently and succinctly presenting information that is relevant to inspectors’ requests.

The following examples represent the types of issues with which Ted has assisted clients in managing and presenting to regulators:

  • Data Integrity: assess risks to products based on retrospective data reviews; investigate and remediate data systems for laboratories and manufacturing processes
  • Aseptic Practice: evaluate and remediate environmental monitoring programs; develop disinfectant efficacy studies; execute and document robust media simulations; investigate sterility failures
  • Regulatory Communication: formulate action plans in response to inspection observations; respond to 483 observations and Warning Letters; draft periodic updates for regulators; advise agencies about manufacturing issues associated with drug shortages
  • Validation: evaluate and remediate API equipment cleaning validation; plan and execute automated and manual visual inspection validations for particulates and container defects; re-validate steam sterilization processes
  • Quality Systems: improve processes for FARs, BPDRs, complaints, investigations, change control and approved suppliers.

In addition to GMP and QS regulation enforcement work, Ted is an experienced litigator. He has represented pharmaceutical companies when deposing plaintiffs, physicians and experts in support of dispositive motions and Daubert motions to exclude expert testimony.

202-312-7048