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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Manufacturers of Protective Barrier Enclosures and Other Stakeholders for certain protective barrier enclosures (“PBE Authorization”) and to Manufacturers of Infusion Pumps and Infusion Pump Accessories and Other Stakeholders for certain infusion pumps and infusion pump accessories (“Infusion Pump Authorization”). FDA revoked the PBE Authorization on August 20, 2020, and the Infusion Pump Authorization on September 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

DATES:

The PBE Authorization is revoked as of August 20, 2020. The Infusion Pump Authorization is revoked as of September 21, 2020.

ADDRESSES:

Submit written requests for single copies of the revocations to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations.

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FOR FURTHER INFORMATION CONTACT:

Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 240-402-8155 (this is not a toll-free number).

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SUPPLEMENTARY INFORMATION:

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On May 1, 2020, FDA issued the PBE Authorization. On May 13, 2020, FDA issued the Infusion Pump Authorization. Of note, these were both “umbrella” Authorizations, i.e., for certain types of products that met the requirements as described in their respective Authorizations. Any product with an individual Authorization is not affected by revocation of these two umbrella Authorizations. Notice of the issuance of the Authorizations was published in the Federal Register on July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the FD&C Act. Subsequent to the issuance of the PBE Authorization, FDA considered new information, specifically from new preliminary evidence from simulated intubation procedure models of potential adverse events that could occur or complications with protective barrier enclosures without negative pressure. Subsequent to the issuance of the Infusion Pump Authorization, FDA considered that no device had been listed under the EUA and that circumstances instead support allowing for tailored requirements of authorization in individual EUAs.

II. EUA Criteria for Issuance No Longer Met and Other Circumstances Make Revocation Appropriate To Protect the Public Health or Safety

Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary of the Department of Health and Human Services may revoke an EUA if, among other things, the criteria for issuance are no longer met or other circumstances make such revocation appropriate to protect the public health or safety. On August 20, 2020, FDA revoked the PBE Authorization because the criteria for issuance were no longer met and other circumstances make such revocation appropriate to protect the public health or safety. Under section 564(c)(2) of the FD&C Act, an EUA may be issued only if FDA concludes that, based on the totality of scientific evidence available, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing such disease or condition and that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product.

Given the new preliminary evidence from simulated intubation procedure models of potential adverse events that could occur or complications with protective barrier enclosures without negative pressure recently reported in literature articles, FDA has concluded it is not reasonable to believe the product may be effective in decreasing healthcare provider exposure to airborne particles and may instead contribute to an increase in healthcare provider exposure to airborne particles. Additionally, the literature articles note potential risks of protective barrier enclosures, such as increased intubation times, lower first-pass intubation success rates, damage to personal protective equipment from intubation boxes, particles escaping from intubation boxes through arm access holes reaching the face of the healthcare provider performing the endotracheal intubation, and human factors issues contributing to increased endotracheal intubation times. Further, based on the same information and the risks to public health, including from the device's potential contribution to an increase in healthcare provider exposure to airborne particles, FDA has concluded under section 564(g)(2)(C) of the FD&C Act that other circumstances make revocation appropriate to protect the public health or safety. Accordingly, FDA has revoked the PBE Start Printed Page 78340Authorization, pursuant to section 564(g)(2)(B) and (C) of the FD&C Act.

On September 21, 2020, FDA revoked the Infusion Pump Authorization because other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act), considering that no device has been listed under the EUA, and circumstances instead support allowing for tailored requirements of authorization in individual EUAs.

III. Electronic Access

An electronic version of this document and the full text of the revocations are available on the internet at https://www.regulations.gov, and https://www.fda.gov/​media/​142374/​download and https://www.fda.gov/​media/​141415/​download.

IV. The Revocations

Having concluded that the criteria for revocation of the Authorizations under section 564(g) of the FD&C Act are met, FDA has revoked the EUAs for certain protective barrier enclosures and certain infusion pumps and infusion pump accessories. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act.

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