FDA Extends Policy Allowing Some Changes to Remote Monitoring Devices Without New 510(k) Submissions

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FDA Extends Policy Allowing Some Changes to Remote Monitoring Devices Without New 510(k) Submissions

Dennis Tosh

October 25, 2023 at 12:35 PM EST

Preserving a version of an enforcement policy established during the early days of the COVID-19 public health emergency (PHE), the FDA will continue to allow limited changes to the indications, functionality, hardware or software of some noninvasive remote monitoring devices used to support patient monitoring without prior submission of a premarket notification (510(k)) to the... Read More

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FDA Extends Policy Allowing Some Changes to Remote Monitoring Devices Without New 510(k) Submissions

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