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

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.

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.