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Navigating FDA Policies for PPE, and Liability Protections

The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19.  The Agency has articulated its guidelines for PPE in one of two ways: (1) through guidance documents and (2) through issuance of “umbrella” Emergency Use Authorizations (EUAs) that cover certain product types.  EUAs have the benefit of potentially providing manufacturers, distributors, and users of PPE with broad liability protections under the Public Readiness and Emergency Preparedness (PREP) Act (so long as the requirements and conditions of the EUA and the PREP Act declaration are met).

We provide here a handy reference chart (updated June 10, 2020) that identifies different types of PPE (masks, face shields, respirators, and gowns), their corresponding EUA or FDA guidance, significant requirements, applicable regulators waivers, and potential liability protection under the PREP Act.

We also provide below a brief overview of FDA’s current policies for PPE, and the liability protections potentially available for each.

Face Masks – For Source Control (Including Use By The General Public)

FDA has both an enforcement policy for face masks, and an EUA that covers face masks intended for use as source control by members of the general public as well as HCPs in healthcare settings (the “Face Mask EUA”).  These masks are intended to cover the wearer’s nose and mouth, in accordance with CDC recommendations, and are not intended to provide liquid barrier or respiratory protection.

Significant Requirements.  The EUA provides specific labeling requirements that are summarized in our reference chart.  Advertising and promotional materials must include a statement that the product has not been FDA cleared or approved and specific disclosures regarding the limitations of FDA authorization during COVID-19.  Manufacturers and distributors must maintain records of the amount of product distributed and the entities receiving the product.

Waivers.  The enforcement policy waives applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, labeling requirements under 21 C.F.R. Parts 801 & 830 (including unique device identification requirements), aside from the specific labeling requirements in the EUA, registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, under 21 C.F.R. Part 803 are not waived.

Face Masks – For Surgical Use

FDA has an enforcement policy for surgical face masks, but to date has not issued an EUA for surgical face masks.  Surgical masks are intended to be worn in a healthcare setting to provide barrier protection from bodily fluids and particulate materials.  These masks are class II devices that require premarket notification (i.e., a 510(k) submission to FDA).

Significant Requirements.  The enforcement policy provides specific labeling requirements that can be found in the EUA and summarized in our reference chart.

Waivers.  The EUA waives applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, labeling requirements (including unique device identification requirements) under 21 C.F.R. Part 801 (aside from the specific labeling requirements in the EUA), registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, under 21 C.F.R. Part 803 are not waived.

Face Shields

FDA has both an enforcement policy and an EUA for face shields.  Face shields are intended for use by HCPs in healthcare settings, cover the front and sides of the face, and provide barrier protection for the wearer.

Significant Requirements.  The EUA provides specific labeling requirements that can be found in the EUA and summarized in our reference chart.  Advertising and promotional materials must include a statement that the product has not been FDA cleared or approved and specific disclosures regarding the limitations of FDA authorization during COVID-19.  Manufacturers and distributors must maintain records of the amount of product distributed and the entities receiving the product.

Waivers.  The EUA waives applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, labeling requirements (including unique device identification requirements) under 21 C.F.R. Part 801 (aside from the specific labeling requirements in the EUA), registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, under 21 C.F.R. Part 803 are not waived.

Respirators – NIOSH Approved (Including N95 Respirators)

FDA has issued an EUA for NIOSH-approved respirators, including 95 respirators.  Respirators, as opposed to masks, have a close facial fit and are designed to form a seal around the nose and mouth.  Most NIOSH-approved respirators are for industrial use only, but during respirator shortages during COID-19, they are permitted for use by HCPs to prevent exposure to airborne particles.  NIOSH maintains a list of authorized N95 respirators here.  Authorized respirators also include those that are passed their recommended shelf life, are not damaged, and have been held in accordance with manufacturers’ storage conditions in strategic stockpiles, and respirators that have been decontaminated using an authorized decontamination system.

Significant Requirements.  All descriptive printed matter related to the use of the respirators must be consistent with NIOSH-approved labeling and CDC recommendations, and the respirators may not be represented as safe or effective against COVID-19.

Waivers.  The EUA does not waive any NIOSH requirements but does waive applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, are not waived.

Non-NIOSH Approved Respirators – NOT FROM CHINA

FDA’s EUA for non-NIOSH approved respirators permits disposable respirators that meet certain performance criteria in foreign countries, bear a CE mark that has been verified by FDA, or that are manufactured by entities that hold one or more NIOSH approvals for other respirator models.  To date, a limited number of respirator models have been authorized under this EUA.

Significant Requirements.  Respirators must be specifically reviewed by FDA and added to Exhibit 1 of the EUA.  In order to be added to Exhibit 1 as an authorized respirator, manufacturers and/or importers must send a request to FDA by email of their intent to import a non-NIOSH approved disposable respirator.  Manufacturer contact information, product labeling, and evidence of conformity to international standards (among other information) must be submitted with the request.  Authorized respirators are subject to random sampling and filtration efficiency performance testing upon importation into the U.S. and may be removed from Exhibit 1 if FDA has reason to believe that a respirator no longer meets the EUA requirements.

All descriptive printed matter related to the use of the respirators must be consistent with NIOSH-approved labeling and CDC recommendations, and the respirators may not be represented as safe or effective against COVID-19.  In addition, the manufacturer must publish instructions for use on its website and include a letter that can be distributed to each end user facility with information on the manufacturer, model, and intended use.

Waivers.  The EUA does not waive any NIOSH requirements but does waive applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, are not waived.

Non-NIOSH Approved Respirators – FROM CHINA

Non-NIOSH approved respirators that are manufactured in China fall under a separate EUA and must be specifically listed in Appendix A to the EUA.  Authorized respirators include those that are manufactured by an entity that holds one or more NIOSH approvals for other respirators models, have regulatory authorization from another jurisdiction (including China or the EU), or were previously listed under Appendix A and have had particulate filtration efficiency assessed by NIOSH with results of indicating a minimum and maximum filtration efficiency greater than or equal to 95 percent.

FDA modified its criteria for authorization of China-produced respirators on May 7 in response to testing by NIOSH that showed respirators failing to meet minimum particulate filtration efficiency of 95 percent (previously reported here).  Respirators that have a failing grade as indicated by NIOSH testing may be re-labeled as face masks and authorized as face masks for use as source control if certain criteria are met under the Face Mask umbrella EUA.  On June 6, 2020, FDA again modified the EUA to, among other changes, no longer permit the respirators to be decontaminated for reuse by HCPs.

Significant Requirements.  Respirators must be specifically reviewed by FDA and added to Appendix A to the EUA.  In order to be added to Appendix A as an authorized respirator, manufacturers and/or importers must send a request to FDA by email of their intent to import the non-NIOSH approved disposable respirators.  Manufacturer contact information, product labeling, and evidence of conformity to international standards (among other information) must be submitted with the request.  Authorized respirators are subject to random sampling and filtration efficiency performance testing upon importation into the United States and may be removed from Appendix A if FDA has reason to believe that the product no longer meets the EUA requirements.

All descriptive printed matter related to the use of the respirators must be consistent with NIOSH-approved labeling and CDC recommendations, and the respirators may not be represented as safe or effective against COVID-19.  In addition, the manufacturer must publish instructions for use on its website and include a letter that can be distributed to each end user facility with information on the manufacturer, model, and intended use.

Waivers.  The EUA does not waive any NIOSH requirements but does waive applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, are not waived.

Gowns, Other Apparel

FDA has both an enforcement policy for all types of gowns, and an EUA that covers non-surgical gowns and other apparel (the “Gown and Apparel EUA”).  The Gown and Apparel EUA covers non-surgical gowns intended for use by HCPs to protect them from the transfer of microorganisms and body fluids.  Non-surgical gowns are worn in low- or minimal-risk patient isolation situations, such as during medical exams and other healthcare settings, and are not intended to be worn during surgical or invasive procedures.  The non-surgical gowns must meet “minimal-to-low barrier protection” standards, meaning Level 1 or Level 2 protection or equivalent under the FDA-recognized standard ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Gowns that require premarket review, including surgical gowns and surgical isolation gowns, are not covered under the EUA.  Also, gowns intended to provide a medium to high level of liquid barrier protection, such as Level 3 or Level 4 under the ANSI/AAMI PB70 standard, are not included within the scope of the EUA.

The EUA also covers other apparel worn by HCPs in a healthcare setting, such as surgical caps, operating-room shoe covers, and surgical helmets.

Significant Requirements.  The EUA provides specific labeling requirements that can be found in the EUA and summarized in our reference chart.  Advertising and promotional materials must include a statement that the product has not been FDA cleared or approved and specific disclosures regarding the limitations of FDA authorization during COVID-19.  Manufacturers and distributors must maintain records of the amount of product distributed and the entities receiving the product.

Waivers.  The EUA waives applicable FDA requirements for good manufacturing practice (GMP) under 21 C.F.R. Part 820, labeling requirements (including unique device identification requirements) under 21 C.F.R. Part 801 (aside from the specific labeling requirements in the EUA), registration requirements under 21 C.F.R. Part 807, and reports of corrections or removals under 21 C.F.R. Part 806.  Requirements for reporting adverse events, however, under 21 C.F.R. Part 803 are not waived.

What Liability Protections Are Available for Manufacturers, Distributors, and HCPs Who Use PPE Subject to EUAs?

Manufacturers, distributors, and HCPs who use PPE that meet the conditions and requirements of the EUA will have broad immunity protection (with some exceptions) under federal law.  We have previously covered PREP Act immunity in our blogs post, including here and here.

The PREP Act authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a declaration (PREP Act declaration) that provides immunity from liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of certain countermeasures during public health emergencies.  The immunity provisions apply to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of covered countermeasures.

The Secretary issued a PREP Act declaration regarding COVID-19 with an effective date of February 4, 2020.  Under the Prep Act declaration, covered countermeasures include antivirals and other drugs and biologics, diagnostic tests, and other medical devices that are approved, cleared, or authorized for investigational or emergency use by FDA.

PPE that meets the requirements and conditions of an EUA are “authorized” by FDA for emergency use, and therefore qualifies as a covered countermeasure under the Prep Act declaration.  This means that entities that develop, make, distribute, or use PPE subject to an EUA are eligible for the broad liability protections of the PREP Act, provided they meet the other conditions of the PREP Act declaration.  Notably, the PPE must be distributed in connection with a federal government contract or authorized emergency response at the federal, regional, state, or local level.

Copyright © 2020, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 164
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Allison Fulton DC SheppardMullin Shareholder Life Sciences FDA
Shareholder

Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

Areas of Practice

Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly advises...

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Keeley A. McCarty, Sheppard Mullin, Government Investigations Lawyer, International Trade Attorney
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Keeley McCarty is an associate in the Government Contracts, Investigations & International Trade Practice Group in the firm's Washington, D.C. office.

Ms. McCarty’s practice focuses on government contracts litigation and counseling, including contract termination appeals, litigation and arbitration of subcontractor disputes, and internal investigations.  Ms. McCarty has counseled clients on a broad range of legal topics, including FAR mandatory disclosure rules, title passage under government contracts, and corporate compliance with the FCPA...

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