New FDA Enforcement Policy for Non-Invasive Remote Patient Monitoring Devices During the COVID-19 Pandemic

As part of its ongoing efforts to address the many healthcare challenges posed by the COVID-19 pandemic, FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand their use for healthcare professionals to monitor patients remotely during the COVID-19 pandemic.

The Policy can be found here

This Policy[1] focuses on how current non-invasive patient monitoring technology can be used to help reduce the burden on hospitals, other healthcare facilities, and healthcare professionals as they continue to face increasing demand for their resources and services.  

Under this new Policy, FDA will not require premarket notification (i.e. “510(k)”) clearance for certain limited modifications made to the indications, claims, functionality, hardware and/or software that measure or detect a patient’s vital signs and that are used to support patient monitoring.

The types of devices covered under this policy include those that measure body temperature, respiratory rate, heart rate and blood pressure. The specific list of covered devices can be found on page 6 of the Policy.  

A summary of the types of modifications subject to this new Policy is provided below.

Modifications to FDA-Cleared Indications, Claims, or Functionality

The new Policy explains that FDA does not believe that a modification to an FDA-cleared indication, claim, or functionality creates an undue risk (and thus no further FDA clearance is necessary) if all of the following conditions are satisfied:

  1. the device is intended for purposes of displaying, printing, or analyzing the physiological parameter(s) that the device measures; 
  2. the device is intended to support or provide the healthcare professional or patient with supporting recommendations about prevention, diagnosis, or treatment of COVID-19 or co-existing conditions; and
  3. the healthcare professional and/or patient can independently review the basis for any diagnostic or treatment recommendations.

FDA recommends that the labeling for these devices include the following information to facilitate the end-user’s understanding of the modifications:

  • a clear description of the available data on the modifications, including device performance, method of determining any clinical recommendations, and potential risks;
  • a prominent notice to both the patient and healthcare professional that the recommendations provided are supportive only and should be neither solely or primarily relied upon for purpose of clinical treatment; information on use conditions, particularly whether the device is intended for periodic spot-checking, trends or continuous monitoring.
  • a clear distinction is provided for the FDA-cleared indications and claims from those that are not; and
  • for those devices for which the use setting has been expanded to include in-home use, adequate lay instructions for such use is provided.

Modifications to Previously Cleared FDA-Cleared Hardware or Software

Consistent with this new Policy, FDA has announced that it also does not intend to require 510(k) clearance for hardware or software modifications to devices that allow for increased remote monitoring to support additional claims or indications.

Examples of such modifications include the connection to a wireless network and/or Bluetooth capability to send a patient’s measurements directly to that individuals’ healthcare provider. As another example, FDA describes how AI may be potentially leveraged by applying algorithms to transform the patient’s vital signs into a novel index or alarm that may aid a healthcare professional in the diagnosis of a patient’s condition or disease state and its severity.

FDA recommends that any changes to FDA-cleared hardware or software be designed, evaluated and validated according to applicable FDA-recognized standards, including those listed here on p. 8 of the Policy.

In addition, manufacturers are advised to develop and implement appropriate cybersecurity controls, including those to maintain device functionality and safety. 

Clinical Decision Support Software for Monitoring Related to COVID-19

Finally, FDA’s new Policy recognizes that software, including mobile apps, may provide a useful tool for monitoring patients with COVID-19 or co-existing conditions and for providing clinical decision support. Accordingly, FDA reminds stakeholders of the amendments to the FDCA made by the 21st Century Cures Act of 2016, which exclude certain clinical decision support software from the definition of device and thus FDA’s jurisdiction.

Consistent with the 21st Century Cures Act, FDA lists the following examples of CDS used for COVID-19 patients that would not need any further approval or clearance:

  • software that uses a patient’s diagnosis to provide a healthcare professional with current practice treatment guidelines for COVID-19 or co-existing conditions, and which provides the source for those guidelines;
  • software that provides healthcare professionals with recommendations to treat a patient with confirmed or suspected COVID-19 consistent with the FDA-required labeling or other reliable sources, including where a healthcare provider does not act in primary reliance on the CDS recommendation;
  • software that compares patient signs, symptoms, or results with available practice guidelines to recommend a specific clinical course of action.  
  • software that is intended to analyze information about a COVID-19 patient’s vital signs (e.g., temperature; heart rate) to provide additional monitoring or care recommendations.

A list of FDA’s digital health polices more generally can be found on page 10 of the Policy.

[1] Given the COVID-19 public health emergency, this Policy takes effect immediately but remains in effect only for the duration of the COVID-19 public health emergency.

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