FDA is issuing this guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Download the final guidance document

Download the final guidance document

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Download the final guidance document

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).

On the FDA website, there is a searchable database of these establishments, before considering souring any product from any company, you should get their FDA Establishment License. The license doesn’t guarantee the product or the felicity are registered with the FDA, but it does show if the facility is registered to sell or distribute medical products in the US.

More information on FDA Establishment Licenses

Establishment Registration & Device Listing

The majority of N95 respirators are manufactured for use in the construction or industrial industry. These masks are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC)

Some N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.

This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA), acting through its Center for Devices and Radiological Health (CDRH), and the Centers for Disease Control and Prevention (CDC), acting through its National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL) (herein referred to as “the Agencies”), provides a framework for coordination and collaboration between the Agencies relating to their regulation of Surgical N95 Respirators and N95 Filtering Facepiece Respirators (FFRs)¹ used in healthcare settings (herein collectively referred to as “N95s”).

A coordinated process will help to ensure that the various regulatory activities of each agency related to N95s are streamlined and harmonized when possible.  The intent of this MOU is to help reduce conflicting and duplicative premarket processes for these devices so that stakeholders can easily and seamlessly discern what steps must be taken to satisfy the applicable regulatory requirements.

Specifically, this MOU (1) describes the mechanisms by which specific information pertaining to N95s may be exchanged between the two Agencies and (2) provides a framework for efficient and coordinated regulatory oversight of N95s intended for use in healthcare settings.

Read more on the FDA website

Considerations for ongoing trials:

• Ensuring the safety of trial participants is paramount. Sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify study conduct accordingly. Study decisions may include those regarding continuing trial recruitment, continuing use of the investigational product for patients already participating in the trial, and the need to change patient monitoring during the trial. In all cases, it is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.
• Sponsors, in consultation with clinical investigators and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), may determine that the protection of a participant’s safety, welfare, and rights is best served by continuing a study participant in the trial as per the protocol or by discontinuing the administration or use of the investigational product or even participation in the trial. Such decisions will depend on specific circumstances, including the nature of the investigational product, the ability to conduct appropriate safety monitoring, the potential impact on the investigational product supply chain, and the nature of the disease under study in the trial.
• Since trial participants may not be able to come to the investigational site for protocol- specified visits, sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants. Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants (for example to carry out procedures necessary to assess safety or the safe use of the investigational product appropriately); in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach.
• In some cases, trial participants who no longer have access to investigational product or the investigational site may need additional safety monitoring (e.g. withdrawal of an active investigational treatment).
• The need to put new processes in place or to modify existing processes will vary by the protocol and local situation. For example, this assessment could include consideration of whether it is appropriate to delay some assessments for ongoing trials, or, if the study cannot be properly conducted under the existing protocol, whether to stop ongoing recruitment, or even withdraw trial participants.
• COVID-19 screening procedures that may be mandated by the health care system in which a clinical trial is being conducted do not need to be reported as an amendment to the protocol even if done during clinical study visits unless the sponsor is incorporating the data collected as part of a new research objective.
• Changes in a protocol are typically not implemented before review and approval by the IRB/IEC, and in some cases, by FDA. Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19. Such changes to the protocol or investigational plan to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19) may be implemented without IRB approval or before filing anamendment to the IND or IDE, but are required to be reported afterwards. The FDA encourages sponsors and investigators to work with their IRBs to prospectively define procedures to prioritize reporting of deviations that may impact the safety of trial participants.
• The implementation of alternative processes should be consistent with the protocol to the extent possible, and sponsors and clinical investigators should document the reason for any contingency measures implemented. Sponsors and clinical investigators should document how restrictions related to COVID-19 led to the changes in study conduct and duration of those changes and indicate which trial participants were impacted and how those trial participants were impacted.
• Changes in study visit schedules, missed visits, or patient discontinuations may lead to missing information (e.g., for protocol-specified procedures). It will be important to capture specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19). This information, summarized in the clinical study report, will be helpful to the sponsor and FDA.
• If scheduled visits at clinical sites will be significantly impacted, certain investigational products, such as those that are typically distributed for self-administration, may be amenable to alternative secure delivery methods. For other investigational products that are normally administered in a health care setting, consulting FDA review divisions on plans for alternative administration (e.g., home nursing or alternative sites by trained but non-study personnel) is recommended. In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented.
• With respect to efficacy assessments, FDA recommends consultation with the appropriate review division regarding protocol modifications for the collection of efficacy endpoints, such as use of virtual assessments, delays in assessments, and alternative collection of research-specific specimens, if feasible. For individual instances where efficacy endpoints are not collected, the reasons for failing to obtain the efficacy assessment should be documented (e.g., identifying the specific limitation imposed by COVID-19 leading to the inability to perform the protocol-specified assessment).
• If changes in the protocol will lead to amending data management and/or statistical analysis plans, the sponsor should consider doing so in consultation with the applicableFDA review division. Prior to locking the database, sponsors should address in the statistical analysis plan how protocol deviations related to COVID-19 will be handled for the prespecified analyses.
• If planned on-site monitoring visits are no longer possible, sponsors should consider optimizing use of central and remote monitoring programs to maintain oversight of clinical sites

This action demonstrates the FDA’s ability to pivot and adapt as the situation warrants in light of a public health emergency. We are taking steps to support diagnostic development considering the urgent need. We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests. Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.

Our guidance provides more specific details for the laboratory and commercial manufacturer communities, but I want to highlight three key elements of the update we are issuing today.

First, we are putting in place a policy for states to take responsibility for tests developed and used by laboratories in their states, similar to the action the FDA granted to the New York State Department of Health last week. States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA. As stated in the guidance, the system does not need to mirror that of New York. Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA. Nor will these laboratories pursue an Emergency Use Authorization (EUA) with the FDA.

Second, we are expanding who the policy outlined in the Feb. 29 guidance applies to. The policy was originally applicable only to laboratories that are certified to perform high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments. Under the update published today, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances. The FDA is aware that numerous commercial manufacturers are developing tests for coronavirus with the intention of submitting an EUA to the FDA. During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. As noted in the guidance, the FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.

Finally, our updated policy provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection. We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

FDA Support of Diagnostics

The FDA has engaged with more than 100 test developers since the end of January, providing templates and advice about the EUA process. More than 80 developers have sought our assistance with development and validation of tests they plan to bring through the EUA process. We’ve granted multiple diagnostic EUAs during this outbreak.

We are updating frequently asked questions for labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more.

We’ve also set up a toll-free line, 1-888-INFO-FDA, to help labs with any questions they may have about the EUA process, our policies or getting supplies.

We know that people want to know the current numbers of tests in the field and how many patients are being tested. This number fluctuates daily as more and more test developers get their tests in the field and start testing patients. At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests.

The FDA continues to maintain operations 24/7 and we are here to support laboratories and test developers as they distribute tests through the country during this time of urgent need.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.