FDA Update: Enforcement Policies for Gowns, Gloves, Sterilizers, Disinfectant Devices and Air Purifiers

Overview


In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on FDA’s issuance of Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency and Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

In Depth


FDA Enforcement Policy for Gowns, Other Apparel, and Gloves

In order to address the recent shortages in availability of personal protective equipment (PPE) for healthcare professionals (HCPs), FDA issued its Enforcement Policy for Gowns, Other Apparel, and Gloves. Under the Enforcement Policy, individuals and HCPs may distribute improvised, non-FDA-cleared gowns, gloves and surgical apparel when no FDA-cleared alternatives are available. FDA manufacturers also may distribute these products without complying with certain FDA requirements, provided the gowns, gloves and surgical apparel meet certain labeling, technical and safety requirements. Below we set out FDA’s current position on various PPE products.

Policy for Gowns, Gloves and Other Apparel Not Intended for Medical Purpose

FDA clarifies that it does not have jurisdiction over gowns, gloves and other apparel that are marketed to the general public for general, non-medical purposes (e.g., construction, industrial use) and, as such, the requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations do not apply to such products. FDA also clarifies that it intends to exercise enforcement discretion to permit individuals, including HCPs (but not companies), to distribute improvised PPE when no alternatives, such as FDA-cleared gowns or gloves, are available.

Gowns, gloves and other apparel that are intended for medical purposes are FDA-regulated medical devices (e.g., those regulated under 21 CFR §§ 878.4040, 880.6250 and 878.4460). FDA will consider factors such as labeling and promotional claims, intended users and modifications (e.g., anti-microbial agents), to determine whether these products are intended for medical purposes. Factors associated with a medical purpose include the following:

  • The product is labeled, marketed or distributed for use by an HCP.
  • The product is labeled, marketed or distributed for use in a healthcare facility or environment.
  • The product includes drugs, biologics, or anti-microbial or anti-viral agents.

Manufacturers and distributors therefore should pay particular attention to labeling, promotional claims and other representations to avoid confusion between gowns, gloves and apparel for personal use and FDA-regulated products for medical settings.

Policy for Gowns and Other Apparel Intended for Medical Purposes

FDA recognizes the consensus standard American National Standards Institute/Association of the Advancement of Instrumentation (ANSI/AAMI) PB70:2003 for liquid barrier performance and classification and the American Society for Testing and Materials (ASTM) F2407 for testing of surgical gowns. Under this Enforcement Policy:

  • “Minimal or low barrier protection” refers to ANSI/AAMI PB70 Level 1 protection or equivalent, or ANSI/AAMI PB70 Level 2 protection or equivalent.
  • “Moderate or high barrier protection” refers to ANSI/AAMI PB70 Level 3 protection or equivalent, or ANSI/AAMI PB70 Level 4 protection or equivalent.

Policy for Non-Surgical Gowns and Minimal-to-Low Barrier Protection Surgical Apparel and Moderate-to-High Barrier Protection Surgical Gowns

In evaluating whether a product under 21 CFR § 878.4040(b) is not a “surgical gown,” FDA will consider whether:

  • It is labeled as a gown other than a surgical gown (g., isolation gown).
  • It is not described in its labeling as a surgical gown.
  • It includes statements relating to barrier protection, and such statements are for only minimal or low barrier protection (g., ANSI/AAMI PB70 barrier protection Level 1 or 2).

In evaluating whether a product under 21 CFR § 878.4040(b) is a “surgical gown,” FDA will consider whether:

  • It is labeled as a surgical gown or surgical isolation gown.
  • It is described as a surgical gown in its labeling.
  • Labeling has statements relating to moderate or high-level barrier protection (g., ANSI/AAMI PB70 barrier protection Level 3 or 4).
  • Labeling has statements indicating it is intended for use during sterile procedures.

Under normal circumstances, FDA regulates gowns not intended for use as “surgical gowns” and other minimal-to-low barrier protection surgical apparel as Class I devices exempt from premarket notification requirements under section 510(k) of the FDCA. These products are normally still subject to other FDA regulatory requirements. See FDA Guidance, Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings. In contrast, FDA typically regulates surgical gowns as Class II devices that are subject to premarket notification requirements under section 510(k) of the FDCA and other FDA requirements. However, under FDA’s Enforcement Policy, FDA will allow the distribution and use of 1) non-surgical gowns and other low-to-minimal barrier protection surgical apparel, and 2) ANSI/AAMI PB70 Level 3 moderate-to-high barrier protection surgical gowns without requiring compliance with certain FDA requirements if they contain appropriate warnings and meet the following criteria to prevent undue risks to health.

Policy for Gloves

Normally, FDA regulates non-powdered patient examination gloves (i.e., worn on the examiner’s hand or finger to prevent contamination between patient and examiner) and surgeon’s gloves (i.e., worn on the hands of operating room personnel to protect a surgical wound from contamination) as Class I (reserved) devices, subject to premarket notification requirements under 510(k) of the FDCA. However, under FDA’s Enforcement Policy, FDA will allow the distribution of these gloves without requiring compliance with certain FDA requirements if they contain appropriate warnings and meet the following criteria to prevent undue risks to health:

FDA Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers

In order to expand the availability of sterilizers, disinfectant devices and air purifiers in light of the COVID-19 public health emergency, FDA issued its Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers. Normally, FDA requires manufacturers of sterilizers, disinfectant devices and air purifiers to submit a marketing application before marketing these devices. FDA regulates sterilizers as Class II devices that require a premarket notification under section 510(k) of the FDCA or as Class III devices that require a Premarket Approval (PMA). FDA regulates disinfectant devices and air purifiers as Class II medical devices that require a 510(k) premarket notification. Once cleared under a 510(k) or approved under a PMA, any modifications to the indications or functionality of these devices generally require a new 510(k) clearance or PMA Supplement from FDA. However, in light of COVID-19, under this Enforcement Policy, FDA does not intend to object 1) to “limited modifications to the indications and functionality of FDA-cleared or -approved sterilizers, disinfectant devices and air purifiers [and accessories]” pertaining to a device’s effectiveness in deactivating or destroying SARS-CoV-2 (i.e., the virus that causes COVID-19), or 2) to sterilizers, disinfectant devices or air purifiers (and accessories) that do not have an FDA clearance or approval.

FDA will not enforce the requirements for prior submission of 510(k) or submission of a PMA, registration and listing requirements, or UDI requirements, provided the products do not create an undue risk. The Enforcement Policy does not apply to sterilizers, disinfectant devices and air purifiers that are “intended to prevent or reduce the risks of hospital acquired infections (HAI) or COVID-19” (i.e., the disease resulting from exposure to the SARS-CoV-2 virus). A manufacturer can show that the products do not create undue risk by meeting the following labeling and performance requirements:

  • Designing, evaluating and validating based on FDA-recognized performance standards specifically detailed in the Enforcement Policy. Manufacturers should carefully review the performance standards outlined for their product type.
  • Labeling the product with the following:
    • A clear description of the available data on the device’s new indications or functions related to SARS-CoV-2 or co-existing conditions, such as device performance and potential risks (g., risk of UV exposure)
    • A clear distinction delineating FDA-cleared or FDA-approved indications from those that are not FDA-cleared or FDA-approved.
    • A general statement about changes that have not been cleared by FDA.
      • “For disinfectant devices, a clear statement of the level of disinfection” (and for UV disinfecting devices, labeling consistent with FDA’s additional labeling recommendations detailed in the Enforcement Policy).

FDA requires that manufacturers document changes to their product in their device master records and change control records so that the information is available to FDA for review, if requested.