Navigating FDA’s Wave of Enforcement Discretion Policies: Device Availability in the Era of COVID-19

COVID-19 Update

Using the Emergency Use Authorization (EUA) process, the Food and Drug Administration (FDA) has taken enormous steps in the last two months to promote vaccine and therapy development and availability, as well as facilitate availability of diagnostic tests, ventilators, personal protective equipment (PPE) and other critical medical technologies. At the same time, FDA has taken steps to make new and modified products more widely available using a policy of enforcement discretion.

Because FDA is an enforcement Agency, it is able to use its discretion and refrain from enforcing its own statutory and regulatory requirements. Prior to the pandemic, this approach had been used by FDA in a variety of circumstances, such as for oversight of “general wellness” medical tools. Since the declaration of the public health emergency in the United States, however, FDA has created enforcement discretion for an unprecedented number of guidance documents, allowing companies to introduce new and/or modified products needed to address the COVID-19 crisis.

The enforcement discretion policies—which are each summarized briefly in the table below, followed by a more detailed discussion of the more notable policies—share several important overarching characteristics:

  • The majority of guidance documents allow for the modification of previously cleared/approved technologies. In other words, FDA does not plan to object if a company has already obtained 510(k) clearance, De Novo authorization or premarket approval (PMA)—depending on the specific type of device and the guidance document—but now plans to change that device to specifically address a need of the public health crisis. This means that companies may implement the changes within the criteria laid out in the specific guidance, and introduce the product to market, without notifying FDA or obtaining premarket clearance or approval for the change.
  • In some instances (e.g., certain digital therapeutic products), FDA is additionally allowing companies to introduce new devices to the market without fully complying with FDA’s requirements.
  • While it is possible for companies to clarify FDA’s policies with the relevant review staff, based on our discussions with the Agency, FDA’s intent is that companies would make the modifications and/or introduce the new products without notifying the Agency. However, where a modification or new product isn’t squarely within the criteria of the guidance, clarification with the Agency would be prudent.
  • The guidance documents vary regarding the specific regulatory requirements that must be adhered to. For example, in some cases, there is enforcement discretion with respect to FDA review and in other cases there is additionally enforcement discretion with respect to registration and listing, compliance with the Quality System Regulation, and other requirements.
  • The enforcement discretion will last until (a) the public health crisis is declared closed or (b) FDA changes the enforcement discretion policy. When the enforcement discretion ends, companies will need to have plans for removing the products from the market and the field. For that reason, obtaining premarket clearance or approval, as needed, between now and the future change in policy would be advisable.

If you have questions regarding any of the guidance documents or the status of a particular product, please contact Yarmela Pavlovic, partner, Manatt Health, at ypavlovic@manatt.com or Adam Finkelstein, counsel, Manatt Health, at afinkelstein@manatt.com.

Guidance Title Type of Product Only for Previously Cleared/Approved? Comments

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff

Thermometers, stethoscopes, ECG and cardiac monitors, pulse oximeters, noninvasive blood pressure monitors, and respiratory rate/breathing frequency monitors, electroencephalographs, cognitive assessment aids, seizure monitoring systems, biofeedback devices, sleep assessment devices, vestibular analysis apparatuses

Clinical Decision Support Tools

Yes. For regulated medical devices, products that have been previously cleared can be modified, consistent with the criteria in the guidance.

Guidance allows for limited modifications to the indications, claims, functionality, or hardware or software of previously cleared devices in order to facilitate use in remote monitoring (e.g., moving from hospital to home environment) and/or facilitate use with COVID-19 patients. FDA does not intend to object to the changes being made without additional FDA clearance. Modification must not create “undue risk” as explained in the guidance.

Also includes some further clarification regarding Clinical Decision Support (CDS) tools that are not considered regulated medical devices.

Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Systems to detect infrared radiation and convert to temperature measurements

Allows modification of previously cleared medical devices, as well as use of nonmedical devices for medical purposes.

Guidance is applicable to all telethermographic systems that are intended for medical purposes, including telethermographic systems that were not previously intended for medical purposes.

If consistent with the conditions in the guidance, FDA does not intend to object to the distribution and use of telethermographic systems intended for initial body temperature assessment for triage use without compliance with specified regulatory requirements.

Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Extracorporeal membrane oxygenation (ECMO) devices and cardiopulmonary bypass devices, accessories, and components that are intended to pump blood or oxygenate blood by (i) moving the blood to a component that pumps/oxygenates the blood, (ii) controlling pump speed, (iii) controlling or monitoring gas flow for the circuit, or (iv) controlling the temperature of the blood

Not applicable to devices intended only for extracorporeal carbon dioxide removal

Yes

Guidance allows for modifications to the indications and design of FDA-cleared approved ECMO devices and cardiopulmonary bypass devices. FDA does not intend to object to the changes being made without additional FDA clearance so long as the modifications do not create “undue risk” and comply with the conditions in the guidance.

Also includes a request for interaction with manufacturers of ECMO devices and cardiopulmonary bypass devices seeking indications greater than six-hour use to work interactively through FDA’s EUA process.

Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Infusion pumps and their accessories used to treat patients who require continuous infusion therapy

Yes

Guidance allows for limited modifications to the indications, functionality, hardware, software, design or materials of FDA-cleared devices used to support patients who require continuous infusion therapy. FDA does not intend to object to the changes being made without prior submission of a premarket notification. Modification must not create “undue risk” as explained in the guidance.

Additionally, FDA does not intend to object to the distribution and use of infusion pump accessories beyond their indicated shelf life and/or duration of use that do not comply with applicable regulatory requirements. Such distribution and use must not create “undue risk” as explained in the guidance.

Also includes information regarding FDA’s intended approach for EUAs for infusion pumps.

Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Clinical electronic thermometers (contact and noncontact)

No (for previously cleared clinical thermometers, see: Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff)

FDA does not intend to object to the distribution and use of clinical electronic thermometers that are not currently 510(k) cleared without any additional FDA clearance so long as they are consistent with the conditions in the guidance.

Also provides recommendations regarding the minimum performance and labeling relevant to clinical electronic thermometers distributed and used subject to the guidance.

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Food and Drug Administration Staff

Face masks and respirators intended for a medical purpose

No (guidance concerns alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available)

FDA does not intend to object to individuals’ distribution and use of improvised PPE when FDA-cleared or FDA-authorized personal protective equipment is unavailable. Similarly, FDA does not intend to object to the distribution and use of face masks, face shields or surgical masks intended for a medical purpose without compliance with specified regulatory requirements. In all cases, the conditions in the guidance must be met.

For face masks marketed to the general public for nonmedical purposes, no FDA approval or authorization is required.

Also provides guidance regarding PPE approved under standards in other countries and includes a request for interaction with manufacturers of face masks and respirators in respect of FDA’s existing EUA for face masks.

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Gowns, gloves, hoods, togas and other apparel

No (guidance concerns alternatives when FDA-cleared apparel is not available)

FDA does not intend to object to the distribution and use of:

  • Gowns not intended for use as “surgical gowns” and other low-to-minimal barrier protection surgical apparel that does not comply with the specified regulatory requirements;
  • ANSI/AAMI PB70 Level 3 moderate-to-high barrier protection surgical gowns that do not comply with the specified regulatory requirements; and
  • Patient examination gloves or surgeon’s gloves that do not comply with the specified regulatory requirements.

In all cases, such distribution and use must not create an “undue risk” as explained in the guidance.

For gloves not intended for a medical purpose, no FDA approval or FDA authorization is required.

Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Sterilizers, disinfectant devices (chemical, physical and ultraviolet), and air purifiers

No (contains guidance applicable to cleared and uncleared devices)

Guidance allows for limited modification to the indications or functionality of FDA-cleared or FDA-approved sterilizers, disinfectant devices and air purifiers pertaining to a device’s virucidal effectiveness against SARS-CoV-2. Such modifications must not create an “undue risk” as explained in the guidance.

FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization without additional FDA clearance under specified regulations.

Guidance also provides recommendations regarding design, evaluation and validation of performance relative to sterilizers, disinfectant devices and air purifiers.

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff

Devices used to provide ventilation and ventilatory support to patients with respiratory failure or respiratory insufficiency, and accessories to such devices

Yes (for products not previously cleared by FDA, the EUA process must be used)

Guidance allows for limited modifications to the indications, claims or functionality, or to the hardware, software or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency without submission of a premarket notification where such modification would otherwise require such a submission. Modifications must not create an “undue risk” as explained in the guidance.

Guidance also provides standards for specific device types, which manufacturers are recommended to adhere to in making modifications as described above.

Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Medical X-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software

Yes. For regulated medical devices, products that have been previously cleared can be modified, consistent with the criteria in the guidance.

Guidance allows for limited modification (of labeling or technological characteristics) of previously cleared imaging devices and analysis software. Policy is intended to increase capacity for COVID-19-related imaging, to allow for conversion of devices for mobile use outside of healthcare facilities and to promote use of software to make radiological findings to aid in diagnosis.

Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Remote visual acuity charts, visual field devices, general-use ophthalmic cameras and tonometers. Includes devices with algorithmic indexes or alarms.

Yes

Allows for limited modification of previously cleared devices. Examples of permitted modifications include changes of indication from healthcare to home setting, conversion of non-portable devices to portable, and changes in hardware or software, to include virtual reality or mobile technology for remote assessment or monitoring capability.

Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Computerized Behavioral Therapy devices, other digital health therapeutic devices for psychiatric disorders, and general wellness and digital health products for mental health or psychiatric conditions

No

Permits distribution of computerized behavioral therapy devices (only those intended for psychiatric conditions) without premarket notification or compliance with other specific requirements. Also provides guidance on general wellness devices for COVID-19-related behavioral health for which FDA will not enforce the FD&C Act.

Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Specific device categories for remote reviewing and reporting of digital pathology slides

Both previously cleared and uncleared devices

Permits modification of cleared devices or marketing of new devices without premarket notification, compliance with good manufacturing or unique device identifier requirements, or adherence to some special controls. Must be for the purpose of remote review (e.g., by pathologist in their home).

Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Fetal dopplers that lay users could be instructed to use in a home setting under the direction of a healthcare provider via prescription

Fetal and maternal monitoring devices that could be used by a healthcare provider via prescription in a home setting

Yes

Allows limited modifications to the indications, functionality, hardware and/or software of cleared devices for purposes such as allowing uses in home settings, permitting remote monitoring or improving portability of devices.

 

Remote Monitoring Devices

In June 2020, FDA issued the immediately in effect guidance Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff. The document describes a policy of enforcement discretion for modifications to the indications, claims, functionality, or hardware or software of previously-cleared devices used in patient monitoring. The purpose was to expand the availability and capability of noninvasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. This includes building up remote monitoring capabilities within a hospital, but perhaps more importantly expanding the availability of devices that can be used for monitoring patients at home such that they would not need to visit medical facilities.

FDA explains that modifications can be made to meet the purposes in the guidance so long as the modifications don’t introduce “undue risk” and provides a number of examples of types of changes that would not create undue risk, as well as criteria for determining whether other types of changes would fall within the policy. In order to make use of the policy, companies must also meet certain conditions, such as clearly indicating which claims and functionality have been cleared by FDA versus those which have not.

Finally, the guidance also provides information on clinical decision support (CDS) tools that are not regulated by FDA. The information builds on the statutory interpretation articulated in FDA’s Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff and includes examples of unregulated products that are specific to COVID-19.

Imaging Systems

FDA’s Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency offers temporary flexibility for manufacturers of X-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software.

In issuing this guidance, FDA’s stated goal is to increase the availability of mobile and portable imaging systems available for use inside and outside of healthcare facilities. These devices, in turn, could help with the diagnosis and treatment monitoring of lung disease in patients with COVID-19 by visualizing pulmonary abnormalities or evaluating the causes of reduced lung function. Underscoring the need for more imaging systems, and more that are mobile, FDA cites the American College of Radiology’s guidance encouraging the deployment of portable radiography units in ambulatory care facilities for use when chest radiographs are considered medically necessary to avoid the infection risk of bringing patients into radiography rooms.

Under the guidance, for the duration of the public health emergency, manufacturers of a wide range of already-cleared X-ray, ultrasound and magnetic resonance imaging systems are permitted to make modifications to the devices’ indications, functionality, hardware, software and materials without premarket notification or submission of a PMA Supplement, in certain cases where the modification does not create an undue risk.

To illustrate low-risk situations, FDA offers several examples. Manufacturers might expand the indications for a device’s use to acquire images where no alternatives exist, such as by changing an extremity-only use to other body parts. They also could expand the device’s mobility by adding batteries. In addition, they could make changes to protect the operator or patient, such as installing radiation barriers or increasing the ability to disinfect the device. FDA also will permit changes to components that do not degrade image quality, where potential hazards are mitigated with designs or labels.

For ultrasound systems, which present a lower risk due to their lack of radiation, FDA is offering even further flexibility, such as modifications for use outside of the approved environment or by a practitioner not trained in sonography or the addition of lung scanning applications and settings.

In a separate section of the guidance, FDA directly addresses software designed to work with imaging systems. The Agency is permitting changes to the indications or functionality of certain image analysis software without premarket notification or PMA supplement in low-risk situations. The guidance describes low-risk situations as modifications for lung segmentation and measurement capabilities; modifications for identification and evaluation of findings associated with COVID-19; and modifications to aid in evaluation and monitoring of COVID-19 patients and their treatment based on metrics derived from images. Notably, FDA will not permit modifications to devices to configure them to be primarily relied upon to diagnose or triage COVID-19 cases, to predict COVID-19 patient response to treatment, or to distinguish COVID-19 from other diseases.

Devices for Treating Psychiatric Disorders

FDA’s Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency is directed at increasing the availability of digital tools for behavioral health treatment.

The stated purpose of the policy is to ensure the availability of behavioral health treatment during the pandemic outside of a clinical setting and without the need for clinical visits while individuals are following “stay at home” orders or practicing social distancing.

To achieve this end, FDA is providing software developers with the flexibility to release digital health therapy devices that are computerized versions of condition-specific behavioral therapy as an adjunct to clinician-supervised outpatient treatment to patients with psychiatric conditions, as well as other digital health therapeutic devices intended to treat psychiatric disorders. FDA will permit distribution of these software devices without premarket notification and without requiring compliance with reports of corrections and removals requirements, registration and listing requirements, and unique device identifier requirements. These flexibilities do not apply to previously cleared devices.

The policy applies only in situations deemed “low risk” by FDA. While FDA encourages developers to discuss specific applications with the Agency, it does give a list of circumstances it believes to be low risk: where verification, validation and hazard analysis demonstrate that the software performs therapy as intended; appropriate cybersecurity precautions are in place; and labeling instructs users to contact a physician before use (even if the device is marketed to a consumer), and the user is required to specifically acknowledge this recommendation. Devices for psychiatric conditions that require urgent clinical intervention are not low risk.

The guidance also contains recommendations for labeling of devices to help users better understand them.

Finally, FDA discusses and reiterates the policy for low-risk general wellness and digital health products for mental health or psychiatric conditions, which are not devices or over which the Agency currently does not enforce applicable regulatory requirements. This guidance remains in effect, and FDA offers several examples of software applications that could be marketed under that guidance during the COVID-19 emergency, such as “[s]oftware functions that display, at opportune times, images or other messages for a substance user who wants to stop addictive behavior due to increased anxiety during the COVID-19 public health emergency,” and apps aimed at “reducing stress, fatigue, or feelings of isolation due to the COVID-19 public health emergency.”

Infusion Pumps and Accessories

FDA’s Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff, issued in April 2020, sets forth a limited, discretionary enforcement policy with respect to limited modifications to the indications, functionality, hardware, software, design or materials of FDA-cleared devices used to support patients who require continuous infusion therapy. Such modifications, for the duration of the public health emergency, will not require prior submission of a premarket notification.

The guidance recognizes the need to increase access to an adequate supply of infusion pumps and accessories and to help foster technologies that allow healthcare providers to maintain a safer physical distance from patients affected by COVID-19. The guidance permits modifications as described above to ensure the availability of the greatest number of such devices.

FDA explains that modifications may be made to relevant devices in accordance with the guidance so long as such modifications do not create an “undue risk.” The guidance offers a number of examples of modifications which it does currently believe would create undue risk, both for changes to indications or functionality of the devices and for hardware, software, design and other material changes to the devices.

Additionally, the guidance notes that infusion pumps work as a system with a number of accessory devices, including tubing, which generally are labeled with specific durations of use and shelf life. Due to an ongoing shortage of such accessory devices, FDA does not intend to object to the distribution and use of infusion pump accessories beyond their indicated shelf life and/or duration of use without additional FDA clearance. However, such distribution and use must not create an “undue risk.”

The guidance recommends (i) that manufacturers reference specified guidance documents and recognized standards for reference when implementing modifications to infusion pumps and accessories and (ii) that modified devices use labeling to help users understand any device modifications.

Finally, FDA states that it is seeking to interact with manufacturers and potential manufacturers of infusion pumps and accessory devices in order to work interactively with such manufacturers through FDA’s Emergency Use Authorization (EUA) process to bring more devices to market. To facilitate this process, FDA provides a list of information that manufacturers seeking to engage in the EUA process for an infusion pump or accessory device should submit for review.

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