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FDA Issues EUA to Increase Availability of Non-Surgical Gowns and Other Apparel

On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by health care personnel (HCPs) as personal protective equipment (PPE) for use in health care settings. FDA intends for the EUA to increase the availability of currently marketed and new non-surgical gowns and other apparel for a medical purpose during the COVID-19 pandemic.

The EUA includes the types of non-surgical gowns and other apparel used in accordance with Centers for Disease Control and Prevention (CDC) recommendations to protect both HCP and patients in low or minimal risk level situations to help prevent the spread of COVID-19.1 Gowns and other apparel included in the EUA’s scope are identified in the table below:

Classification Regulation

Device Type

Product Code

Class

21 CFR 878.4040

Conductive shoe and shoe cover

BWP

I (exempt)

21 CFR 878.4040

Operating-room shoes

FXW

I (exempt)

21 CFR 878.4040

Surgical apparel accessory

LYU

I (exempt)

21 CFR 878.4040

Non-surgical isolation gown

OEA

I (exempt)

21 CFR 878.4040

Operating-room shoe cover

FXP

I (exempt)

 21 CFR 878.4040

Surgical helmet

FXZ

I (exempt)

 21 CFR 878.4040

Surgical cap

FYF

I (exempt)

FDA also included as part of this EUA gowns and other apparel that have been decontaminated pursuant to the terms and conditions of an authorized discontinuation system. Furthermore, in the circumstances of this public health emergency, FDA has authorized HCPs to use the gowns and other apparel covered by the EUA when treating any patient, not only when treating patients with suspected or confirmed COVID-19.

The following items are outside the scope of the EUA:

  • Class I (reserved) and II devices such as surgical gowns (product code: FYA) and surgical isolation gowns (product code: FYC)

  • Gowns intended to provide Level 3 or Level 4 liquid barrier protection or equivalent under the FDA-recognized standard ANSI/AAMI PB70Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

The EUA identifies additional requirements such as proper labeling and meeting “minimal-to-low barrier protection,” which means Level 1 or Level 2 protection or equivalent under ANSI/AAMI PB70. No printed matter relating to the use of the authorized gown or other apparel may represent or suggest that the authorized product is safe or effective for the prevention or treatment of patients during the COVID-19 pandemic.

Refer to the full text of the EUA for a complete description of requirements and responsibilities.

Since the advent of the COVID-19 public health emergency, FDA has granted the following PPE-related EUAs:

FDA also has issued guidance on its enforcement discretion for face masks and respiratorsgowns, other apparel, and gloves, and a temporary policy for manufacturing hand sanitizer products.


Footnotes

  1. Please see FDA’s letter to Health Care Providers entitled “Surgical Mask and Gown Conservation Strategies” and CDC’s “Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings” guidance for more information.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 148
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Heili Kim Product Safety & Compliance Attorney Faegre Drinker Biddle & Reath Washington, D.C.
Partner

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.

Regulatory Compliance

Heili collaborates with companies whose products are regulated by the FDA to evaluate...

202-312-7067
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
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...

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