On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance). This guidance updates previous guidance issued during the COVID-19 pandemic and is meant to provide clarity on current enforcement policies now that the public health emergency is declared over.
Limited Modifications to Indications or Functionality. In its guidance, FDA announced that the administration does not intend to object to limited modifications to the indications or functionality of certain non-invasive remote monitoring devices that are used to support patient monitoring that allow for increased remote monitoring capability without prior submission of a 510(k) where the modification does not create undue risk and does not directly affect the physiological parameter measurement algorithm even if such modifications would have required a 510(k) submission previously.
Included Devices. The guidance includes a table of included devices that measure or detect common physiological parameters, e.g., monitoring spirometer, apnea monitor, or electrocardiograph. As an example, FDA noted that a modification to the indications to allow for in-home use as opposed to hospital settings does not create such undue risk and does not affect the physiological parameter measurement algorithm.
Limited Hardware or Software Architecture Modifications. Additionally, FDA does not intend to object to limited hardware or software architecture modifications to certain non-invasive remote monitoring devices, e.g., device connectivity modifications (wireless and/or Bluetooth) that are used to support patient monitoring that allow for increased remote monitoring capability without prior submission of a 510(k) when the modification does not create undue risk and where the modifications do not directly affect the physiological parameter measurement algorithm.
The guidance provides that manufacturers of the non-invasive remote monitoring devices listed in Table 1 of the guidance are still required to submit a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act to FDA and receive FDA clearance prior to marketing these devices in the United States, to the extent the devices are not 510(k) exempt, as well as comply with post-marketing requirements. The guidance only applies to certain modifications made to these already legally marketed devices.
Caveats. Modifications to the indications or functionality that could create undue risk or that could affect the physiological parameter measurement algorithm would not be within the scope of the policy articulated in the guidance and would generally require submission of a 510(k). Modifications to add new indications or device software functions to allow for remote programming of the device, remote control of the device, generation of new alarms, measurement of new physiological parameters, or a change from prescription to over-the-counter use would not be within the scope of FDA’s policy, for example.
Why this Guidance is Important
This risk-based approach is good news for the Remote Patient Monitoring and the Remote Therapeutic Monitoring industry. Manufacturers of certain devices that measure or detect common physiological parameters may now make certain modifications and bring these modifications to market without having to undertake the 510(k) clearance process.
비즈니스 운영 및 업계별 문제와 관련된 중요한 법적 고려 사항을 탐색하는 데 도움이 되는 리소스를 보유하고 있습니다. 궁금한 점이 있으면 해당 자료의 저자, Foley 관계 파트너 또는 의료 서비스 실무 그룹에 문의하시기 바랍니다.
