October 21, 2020

Volume X, Number 295

October 21, 2020

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FDA Amends Imported Non-NIOSH Approved Respirator EUA

In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators (FFR or respirator). Exhibit 1 lists authorized respirators.

As a result of the revision, imported, non-NIOSH approved respirators not manufactured in China can be authorized by meeting one of three criteria:

  1. Disposable FFRs that have been designed, evaluated, and validated to meet a given performance standard and have corresponding acceptable product classifications as outlined in Table 1 of the EUA.

  2. Disposable FFRs that conform to Personal Protective Equipment (PPE) Directive 89/686 EEC (for those placed in distribution prior to April 21, 2019) or that conform to PPE Regulation (European Union (EU)) 2016/425 (for those placed in distribution after April 21, 2019), as evidenced by a CE Mark, and the CE Mark as been authenticated and verified by the FDA.

  3. Disposable FFRs that are manufactured by entities that hold one or more NIOSH approvals, that have been verified by the FDA, for FFRs, and that are produced by the NIOSH approval holder in accordance with the applicable standards of authorization in another country.

If FDA confirms eligibility, FDA will add the respirator to the list of authorized respirators in Exhibit 1. Authorized respirators are also subject to random sampling and filtration efficiency performance testing upon importation into the United States.

In addition to changes regarding eligibility criteria, the June 6 LoA removed decontaminated respirators with exhalation valves from the EUA. The June 6 LoA also added requirements related to advertising and promotion and the requirement of samples for testing when requested by the FDA. For a full list of the requirements for authorized respirators, please reference the full June 6 LoA.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 175

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Gary Rom Health Care Lawyer Faegre Drinker
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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...

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Michael B. Gastineau Regulatory Attorney Faegre Drinker Biddle & Reath Indianapolis, IN
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Michael helps companies navigate the complex world of FDA-regulated drug and device development and product commercialization. He has experience with the many varied aspects of regulated human subjects research, particularly relating to clinical trial contracting. Michael helps clients negotiate clinical trial agreements, draft pre-clinical trial agreements and HCP consulting agreements. He also advises clients in other health law matters, including purchase and sell agreements and the creation of regulatory compliance and risk plans.

Before joining the firm, Michael was a consultant at one of the world’s largest pharmaceutical companies, where he was responsible for communicating its position on a variety of global contract issues.

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Heili Kim Product Safety & Compliance Attorney Faegre Drinker Biddle & Reath Washington, D.C.
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Product safety and compliance are Heili Kim’s priorities. She blends inside knowledge from her role as regulatory counsel for the Food and Drug Administration (FDA) with business pragmatism and international perspective to guide food, dietary supplement, cosmetic and medical device clients on regulatory issues and advertising. She seeks to understand each client’s risk tolerance, objectives and goals to provide client-focused advice that will help the company thrive.

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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...

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