The Food and Drug Administration (FDA), the US regulating authority, has published a revised enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during COVID-19.
The present document actually constitutes a new version of the policy issued by the Agency earlier in March 2020 and updated for the first time later in June 2020. The FDA finds it necessary to make certain amendments to the document to keep it up-to-date due to the extension of the information collected during the pandemic.
It is also important to mention that the present FDA guidance is subject to immediate implementation without prior public consultations, while the interested parties are still allowed to submit their comments and suggestions. The authority also states that the provisions of the policy would remain effective only within the period of the COVID-19 outbreak and public health emergency associated thereto since the measures implemented by the policy are of temporary and extraordinary nature. Thus, upon the termination of the pandemic, the general rules should be applied.
The present FDA enforcement policy is intended to implement special measures necessary to expand and ensure the availability of non-invasive remote monitoring devices actively used in the context of the pandemic, and to avoid potential shortages in the supply of such devices. The aforementioned devices are being used to exclude direct contacts between healthcare professionals and patients to reduce the risk of infection associated thereto.
The scope of the guidance covers Class II medical devices intended to measure or detect common physiological parameters. The document contains a list of the devices subject to regulation under the present enforcement policy which includes, inter alia, the following devices:
- Diagnostic spirometers, regulated under 21 CFR 868.1840 with product codes BZG, PNV,
- Monitoring spirometers, regulated under 21 CFR 868.1850 with product code BZK,
- Breathing frequency monitors, regulated under 21 CFR 868.2375 with product code BZQ,
- Noninvasive blood pressure measurement systems, regulated under 21 CFR 870.1130 with product code DXN,
- Electrocardiographs, regulated under 21 CFR 870.2340 with product code DPS, and other devices.
All medical devices covered by the scope of the enforcement policy could be connected to a wireless network to transmit the data collected from sensors directly to healthcare professionals. It is also important to mention that some of the devices could not only transmit the raw data but also process it using special pre-defined algorithms to provide healthcare professionals with additional information (e.g. alarms).
General Approach to the Remote Monitoring Devices
As it was already mentioned in the initial guidance, in order to ensure and expand the uninterrupted availability of non-invasive remote monitoring devices intended to be used in the COVID-19 context, the Agency is not going to object to certain changes or modifications to the indications for use, claims made by the manufacturer, functionality, hardware or software of medical devices covered by the scope of the present enforcement policy, providing that such changes do not cause an adverse effect on the safety and effectiveness of the medical devices subject to changes. This exclusion should be applied only during the public health emergency associated with the outbreak of the novel coronavirus. Under the exclusion, the medical device manufacturers are allowed to waive the requirement on mandatory submission of a 510(k) premarket notification which is required in such cases under the general rules. Aside from this exclusion, the present enforcement policy actually implements certain additional exclusions medical device manufacturers could benefit from.
According to the document, the Agency is not going to object to the modifications described therein, in case of such modifications are intended to improve the functional capabilities of non-invasive remote monitoring devices and their performance. At the same time, the authority additionally emphasizes that such changes should not affect the physiological parameter measurement algorithms.
The Agency also recommends the manufacturers to take into consideration the requirements set forth in the applicable FDA-recognized voluntary consensus standards – the standards approved by the authority to be used to demonstrate conformity with certain safety and performance requirements – including, inter alia, the following ones:
- ANSI/AAMI ES60601-1:2005 (R2012) – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance;
- IEC 60601-1-2:2014 – Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests;
- ANSI/IEEE C63.27:2017 – American National Standard for Evaluation of Wireless Coexistence;
- IEC 62304:2015 – Medical Device Software – Software Life Cycle Processes, and other applicable standards.
It is also important to mention that since the non-invasive remote monitoring devices require to be connected to the network when being used for the intended purpose, the medical device manufacturers shall also duly implement the measures and controls necessary to address potential cybersecurity matters.
Clinical Decision Support Software
Some of the remote monitoring devices could be also used by healthcare professionals to provide clinical decision support. In order to fall within the scope of the clinical decision support (CDS) software, the product in question should meet all criteria provided below:
- It should be not intended to acquire, process, or analyze a medical image or a signal,
- It should be interred to display, analyze or print medical information about a particular patient or other medical information,
- It should be intended to support or provide recommendations to healthcare professionals with regard to the prevention, diagnosis, or treatment,
- It should be designed in a way allowing the healthcare professional to review the initial data the recommendations provided by the products are based on, providing that the healthcare professional would not rely primarily on such recommendations provided by the product.
In order to assist medical device manufacturers and other parties involved in operations with medical devices in applying the provisions described hereinabove, the Agency also provides examples of non-device functions falling within the scope of exclusion under section 520(o) of the Food, Drug, and Cosmetic Act, namely:
- Software that uses a patient`s diagnosis to provide a healthcare provider with current practice treatment guidelines for COVID-19 or co-existing conditions, and provides the source of the guidelines;
- Software that provides healthcare providers with recommendations on the use of a medical device to treat a patient with confirmed or suspected COVID-19 that are consistent with the FDA-required labeling or that are described in other sources, such that the healthcare provider does not rely primarily on the software’s recommendation;
- Software that compares patient signs, symptoms, or results with available practice guidelines (institutions-based or academic/clinical society-based) to recommend condition-specific diagnostic tests, investigations, or therapy or triaging patient care. The practice guidelines are described as the basis for the recommendation and provided for the health care professional to review, such that the healthcare provider does not rely primarily on the software’s recommendations; and
- Software functions that are intended to analyze medical information about a patient diagnosed with COVID-19, such as temperature and heart rate, to provide recommendations to the health care professional for opportunities for additional monitoring or care, and the basis for the recommendation, such as CDC guidelines, is provided so that the health care professional does not rely primarily on the recommendation.
Summarizing the information provided here above, the present FDA enforcement policy describes the extraordinary measures temporarily introduced by the Agency to ensure and expand the availability of non-invasive remote monitoring devices intended to be used in the context of the COVID-19 outbreak and public health emergency associated thereto.
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