Guidances with Digital Health Content

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class="lcds-share__item"> <a href="mailto:?subject=Guidances%20with%20Digital%20Health%20Content&body=https://www.fda.gov%2Fmedical-devices%2Fdigital-health-center-excellence%2Fguidances-digital-health-content" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>The guidance documents listed here are FDA guidances with Digital Health content and are intended to provide clarity on the FDA's regulation of digital health products.</p><hr><h3>List of FDA Guidance Documents with Digital Health Content</h3><div class="lcds-datatable lcds-datatable--ckeditor"><div class="table-responsive"><table class="table" aria-readonly="true" data-column-defs="[{ "targets": 0, "type": "date" }]" data-order="[ 0, "desc" ]" data-page-length="100" data-paging="true" data-searching="true" role="grid"><thead><tr><th style="width:76px;" scope="col">Issue Date</th><th style="width:1238px;" scope="col">Guidance</th><th scope="col">Guidance Status</th></tr></thead><tbody><tr><td>01/07/2025</td><td><a href="/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing" data-entity-type="node" data-entity-uuid="18f631dc-c604-432c-a20c-97927714433a" data-entity-substitution="canonical" title="Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations">Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations</a></td><td>Draft</td></tr><tr><td class="text-align-right" style="width:76px;">12/04/2024</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence" data-entity-type="node" data-entity-uuid="c3412832-042d-4454-bc89-289cdd0e8238" data-entity-substitution="canonical" title="Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions">Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/27/2023</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions" data-entity-type="node" data-entity-uuid="ca89a6a7-bff4-4eac-beaa-8b616b80e66c" data-entity-substitution="canonical" title="Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions">Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">08/11/2023</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices" data-entity-type="node" data-entity-uuid="a1ec603e-0593-4c8b-841d-19c0ecbaa051" data-entity-substitution="canonical" title="Off-The-Shelf Software Use in Medical Devices">Off-The-Shelf Software Use in Medical Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">06/14/2023</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions" data-entity-type="node" data-entity-uuid="8332e47b-abde-412b-a986-75827d1bfcf3" data-entity-substitution="canonical" title="Content of Premarket Submissions for Device Software Functions">Content of Premarket Submissions for Device Software Functions</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/28/2022</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software" data-entity-type="node" data-entity-uuid="db47dab9-1504-468b-a2f4-4d40766bb282" data-entity-substitution="canonical" title="Clinical Decision Support Software">Clinical Decision Support Software</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">12/22/2023</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations" data-entity-type="node" data-entity-uuid="e145ad98-149e-4576-9796-0ebc86e6de57" data-entity-substitution="canonical" title="Digital Health Technologies for Remote Data Acquisition in Clinical Investigations">Digital Health Technologies for Remote Data Acquisition in Clinical Investigations</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">11/04/2020</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/multiple-function-device-products-policy-and-considerations" data-entity-type="node" data-entity-uuid="d2ff0ab3-6a41-414a-a609-c2a0599bf139" data-entity-substitution="canonical" title="Multiple Function Device Products: Policy and Considerations">Multiple Function Device Products: Policy and Considerations</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/27/2019</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act" data-entity-type="node" data-entity-uuid="a0748a62-3b74-41b7-8dae-19aa06e3a903" data-entity-substitution="canonical" title="Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act">Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/28/2022</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications" data-entity-type="node" data-entity-uuid="4d1e4a16-d2e8-4ce6-b53b-79785fab0ca2" data-entity-substitution="canonical" title="Policy for Device Software Functions and Mobile Medical Applications">Policy for Device Software Functions and Mobile Medical Applications</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/28/2022</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices" data-entity-type="node" data-entity-uuid="468d0e7a-00d6-4bee-8fc1-af174ff0b31e" data-entity-substitution="canonical" title="Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices">Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/27/2019</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices" data-entity-type="node" data-entity-uuid="c0c5e500-b102-4642-bd13-1cd0ef7921ce" data-entity-substitution="canonical" title="General Wellness: Policy for Low Risk Devices">General Wellness: Policy for Low Risk Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">12/20/2017</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways" data-entity-type="node" data-entity-uuid="287f22a8-bdc7-45a3-ba4e-99dc00a328de" data-entity-substitution="canonical" title="Medical Device Accessories - Describing Accessories and Classification Pathways">Medical Device Accessories - Describing Accessories and Classification Pathways</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">12/08/2017</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/software-medical-device-samd-clinical-evaluation" data-entity-type="node" data-entity-uuid="4faf8aaa-1ca6-4982-a216-5431f369cd08" data-entity-substitution="canonical" title="Software as a Medical Device (SAMD): Clinical Evaluation">Software as a Medical Device (SAMD): Clinical Evaluation</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">10/25/2017</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device" data-entity-type="node" data-entity-uuid="5b6622b5-e9c4-474f-a2b7-b9682a885a31" data-entity-substitution="canonical" title="Deciding When to Submit a 510(k) for a Software Change to an Existing Device">Deciding When to Submit a 510(k) for a Software Change to an Existing Device</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/06/2017</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/design-considerations-and-pre-market-submission-recommendations-interoperable-medical-devices" data-entity-type="node" data-entity-uuid="d30fba54-45b5-4833-8a3d-dd857dce5df1" data-entity-substitution="canonical" title="Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices">Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">12/28/2016</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices" data-entity-type="node" data-entity-uuid="7a1bc3a0-4dde-46d5-ac82-c5eca87723d2" data-entity-substitution="canonical" title="Postmarket Management of Cybersecurity in Medical Devices">Postmarket Management of Cybersecurity in Medical Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">02/03/2016</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices" data-entity-type="node" data-entity-uuid="727d611a-2f8d-42d4-ac31-0368b3746e77" data-entity-substitution="canonical" title="Applying Human Factors and Usability Engineering to Medical Devices">Applying Human Factors and Usability Engineering to Medical Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">08/14/2013</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-technology-medical-devices-guidance-industry-and-fda-staff" data-entity-type="node" data-entity-uuid="2adab9a1-12f7-43f0-91d8-8f4e3c52d187" data-entity-substitution="canonical" title="Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff">Radio Frequency Wireless Technology in Medical Devices</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/28/2022</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/computer-assisted-detection-devices-applied-radiology-images-and-radiology-device-data-premarket" data-entity-type="node" data-entity-uuid="ad094dd8-8199-4f45-9087-89caede7079d" data-entity-substitution="canonical" title="Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions">Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">09/28/2022</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/clinical-performance-assessment-considerations-computer-assisted-detection-devices-applied-radiology" data-entity-type="node" data-entity-uuid="f29e27e5-286c-40d8-b228-c43091ab98a6" data-entity-substitution="canonical" title="Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions">Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">03/18/2010</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/acceptable-media-electronic-product-user-manuals" data-entity-type="node" data-entity-uuid="e4841c73-5fbf-4ac6-b122-dcc02e0b33d1" data-entity-substitution="canonical" title="Acceptable Media for Electronic Product User Manuals">Guidance: Acceptable Media for Electronic Product User Manuals</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">02/09/2005</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/information-healthcare-organizations-about-fdas-guidance-industry-cybersecurity-networked-medical" data-entity-type="node" data-entity-uuid="a0715a28-417e-44ff-a4e1-d221f50d5b9e" data-entity-substitution="canonical" title="Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"">Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"</a></td><td>Final</td></tr><tr><td class="text-align-right" style="width:76px;">01/14/2005</td><td style="width:1238px;"><a href="/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software" data-entity-type="node" data-entity-uuid="4f95d962-25bc-4611-9808-f24b3526cf27" data-entity-substitution="canonical" title="Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software">Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software</a></td><td>Final</td></tr></tbody></table></div></div><h3>Resources</h3><ul><li><a href="https://public4.pagefreezer.com/browse/FDA/01-03-2024T13:19/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices-unpublished/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023">Webinar - Content of Premarket Submissions for Device Software Functions - July 20, 2023</a></li><li><a href="https://public4.pagefreezer.com/browse/FDA/31-12-2022T07:59/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-clinical-decision-support-software-final-guidance-10182022">Webinar - Clinical Decision Support Software Final Guidance - October 18, 2022</a></li><li><a href="https://public4.pagefreezer.com/browse/FDA/31-12-2022T07:59/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-cybersecurity-medical-devices-quality-system-considerations-and-content-premarket" title="Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance - 06/14/2022">Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance - June 14, 2022</a></li><li><a href="/drugs/news-events-human-drugs/digital-health-technologies-dhts-remote-data-acquisition-draft-guidance-02102022" data-entity-type="node" data-entity-uuid="8d3e345a-b42c-4820-8977-ec42c64c641e" data-entity-substitution="canonical" title="Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance - 02/10/2022">Webinar - Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance - February 10, 2022</a></li><li><a href="https://public4.pagefreezer.com/browse/FDA/15-08-2023T12:42/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-multiple-function-device-products-policy-and-considerations-09102020-09102020">Webinar - Multiple Function Device Products: Policy and Considerations - September 10, 2020</a></li><li><a href="https://public4.pagefreezer.com/browse/FDA/28-07-2023T13:45/https://www.fda.gov/medical-devices/webinar-changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act">Webinar Materials - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance (2019)</a></li></ul>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" 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