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FDA Policy Provides Enforcement Relief Regarding Certain Medical Devices Due to Pandemic

Key Takeaways:

  • What Happened: FDA announced temporary relief from certain premarket regulatory requirements pertaining to certain new or modified medical devices intended for use against the novel coronavirus.
  • Who’s Impacted: Manufacturers and distributors of certain medical sanitizers, disinfectant devices, and air purifiers.
  • What Should They Consider Doing in Response: Manufacturers may be able to bring covered new or modified medical devices to market more quickly while the policy remains in effect.
  • By When Should They Act: The temporary policy will remain in effect for the duration of the COVID-19 public health emergency.

Manufacturers of sterilizers, disinfectant devices, and air purifiers used in medical settings to combat the COVID-19 pandemic now have greater regulatory flexibility, thanks to new enforcement guidance from the Food and Drug Administration (FDA).

The covered products include those intended to sterilize or disinfect certain medical devices, or to kill or remove pathogens from the air. While the enforcement policy is in effect, FDA intends to allow limited modifications to the indications or functionality of such devices that have already been approved by FDA, as well as distribution or use of such devices that have not yet received FDA pre-market approval.

The new policy is effective immediately. It will remain in effect for the duration of the public health emergency announced by the Department of Health and Human Services on January 31. FDA’s policy complements similar steps taken separately to facilitate the manufacture and availability of hand sanitizers.

1. Background

Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers of certain sterilizers, disinfectant devices, and air purifiers are subject to FDA premarket requirements for medical devices. For new or high-risk devices, manufacturers must submit a premarket approval application (“PMA”). For devices similar to those that FDA has previously approved, manufacturers must submit a premarket notification under FFDCA § 510(k). In both cases, after FDA approves or clears these devices, premarket FDA approval is generally required for modifications to the indications or functionality of the devices.

The sterilizers, disinfectant devices, and air purifiers covered by FDA’s COVID-19 enforcement policy are all regulated as “medical devices” under the FFDCA:

  • Sterilizers and high-level disinfectants used on critical or semi-critical medical devices and other FDA-regulated disinfectant devices. 
  • Air purifiers intended for medical purposes to kill pathogens in the air by exposure to UV radiation or to remove such pathogens through filtration.

Note that many hard surface chemical disinfectants and non-medical devices making antimicrobial claims are separately regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by the Environmental Protection Agency (“EPA”). For more information on recent steps taken by EPA in connection with these products, please see our alert available here.

2. Enforcement Discretion During COVID-19 Emergency

FDA’s new enforcement policy allows manufacturers to make limited modifications to the indications or functionality of previously approved sterilizers, disinfectant devices, or air purifiers, so long as the modifications pertain to the device’s effectiveness against the novel coronavirus. 

The policy also covers the distribution and use of sterilizers, disinfectant devices, or air purifiers that are intended to be effective at killing the novel coronavirus but do not already have premarket authorization. FDA is taking this action because it sees the novel coronavirus, SARS-CoV-2, as among the least resistant to these kinds of devices, due to its size and envelopment in a lipid bilayer. The policy applies only to products intended to sterilize or disinfect medical devices, or to kill or remove pathogens from the air. It explicitly does not apply to products intended to prevent or reduce the risks of hospital-acquired infections or COVID-19 in human beings. 

For the duration of the public health emergency related to the COVID-19 pandemic, FDA “does not intend to object” to limited modifications to the indications or functionality of specific FDA-cleared or FDA-approved sterilizers, disinfectant devices, and air purifiers pertaining to a device’s virucidal effectiveness against the novel coronavirus, without compliance with the regulatory requirements listed below, where such devices do not create an undue risk in light of the current pandemic:

  • Prior submission of a premarket notification under FFDCA § 510(k) and 21 C.F.R. § 807.81.
  • Prior submission of a PMA Supplement under FFDCA § 515 and 21 C.F.R. § 814.39.
  • Registration and Listing requirements in 21 C.F.R. Part 807.
  • Unique Device Identification requirements in 21 C.F.R. Part 830 and 21 C.F.R § 801.20.

FDA believes that such devices will not present an undue risk where manufacturers meet certain performance and labeling recommendations to ensure product effectiveness and help users to better understand the new devices or device modifications. It recommends that manufacturers follow specified consensus standards for product design, evaluation, and performance validation for different types of sterilizer, disinfectant device, and air purifier distributed under the temporary policy. Additionally, FDA recommends that manufacturers include at least the following label statements in the labeling for such devices:

  • A clear description of the available data on the device’s new indications or functions related to SARS-CoV-2;
  • A clear distinction between FDA-cleared or FDA-approved indications and those that are not FDA-cleared or FDA-approved, as well as a general statement about changes made without FDA clearance;
  • For all disinfectant devices, a clear statement of the level of disinfection; and
  • For UV disinfecting devices, a caution about the effectiveness and use of such devices as an adjunct to existing reprocessing practices, appropriate UV hazard warning and dosage labeling, instructions for use, and various other label statements.

Manufacturers must also document all changes to their devices in their device master records and change control records, and must make this information available to FDA upon request.

According to FDA, examples of devices to which the new policy would apply include a pre-cleared steam sterilizer for which the manufacturer would like to include a labeling statement of effectiveness in killing the novel coronavirus, and a new medical air purifier that is effective in filtering out dust particles and bacteria and for which the manufacturer would like to modify the filter mesh size in order to filter out viruses.

© 2020 Beveridge & Diamond PC

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Alan J. Sachs, Beveridge Diamond, Food biotechnology lawyer, bioenergy industries attorney
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries. His practice includes all aspects of the U.S. Environmental Protection Agency’s (EPA) regulation of pesticides, including the manufacture, import, distribution, labeling, registration, and use of all types of consumer and agricultural pesticide products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). As part of his FIFRA legal practice, Alan frequently supports the data rights objectives of Beveridge &...

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Mark N. Duvall Chemicals Regulation Attorney Beveridge & Diamond Washington, DC
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Mark has over two decades of experience working in-house at large chemical companies. 

His focus is product regulation at the federal, state, and international levels across a wide range of programs, and occupational safety and health.

He leads the firm’s Chemicals group. His experience under the Toxic Substances Control Act (TSCA) includes enforcement actions, counseling, rulemaking, advocacy, and legislative actions. Since the enactment of TSCA amendments in 2016, he has been heavily involved in advocacy, compliance activity, and litigation arising from EPA's implementation of these amendments. He also works with foreign counterparts to TSCA, including REACH and CEPA.

He is also a leader of the firm’s Occupational Safety and Health practice. He has extensive experience with OSHA and state OSHA inspections, enforcement litigation, compliance counseling, advocacy, and rulemaking. He has counseled clients on the EPA risk management program requirements under Section 112(r) of the Clean Air Act and state worker protection programs, and on inspections by the Chemical Safety and Health Investigation Board.

He has extensive experience with the Federal Insecticide, Fungicide, and Rodenticide Act, particularly with respect to regulation of antimicrobials, and with the Biocidal Products Directive in Europe.

He heads the firm’s FDA practice, having worked on FDA regulation of food and food additives, dietary supplements, drugs, medical devices, and cosmetics, and European counterparts. He is knowledgeable about human testing requirements, having served as the Chair of an institutional review board for several years.

He has counseled clients on the regulation of consumer products by the Consumer Product Safety Commission and the Federal Trade Commission. He has reviewed hundreds of green marketing claims and counseled on federal, state, and international regulation of such claims.

He has worked on green chemistry issues at the federal and state levels, as well as a variety of voluntary programs that affect products. He has helped clients with the Emergency Planning and Community Right-to-Know Act, the Controlled Substances Act, the Chemical Weapons Convention, and other chemicals-related requirements.

He has advised clients and written and lectured on the regulation of the products of nanotechnology by FDA and by EPA under FIFRA and TSCA, and on related product stewardship issues.

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Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
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Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

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