MedWatch Forms for FDA Safety Reporting

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class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <h2>Voluntary Reporting For use by Health Professionals, Consumers, and Patients</h2> <p>Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.</p> <div class=" panel-group" id="accordion_618144" role="tablist" aria-multiselectable="true"> <div title="MedWatch for Health Professionals FDA Form 3500 pdf" open="yes" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_6741488a95c66"> <h2 class="panel-title"> <a role="button" data-toggle="collapse" data-parent href="#6741488a95c66" aria-controls="6741488a95c66">MedWatch for Health Professionals FDA Form 3500 pdf</a> </h2> </div> <div id="6741488a95c66" class="panel-collapse collapse in" role="tabpanel" aria-labelledby="heading_6741488a95c66"> <div class="panel-body"> <p><strong><a href="/media/76299/download">Form FDA 3500 - Voluntary Reporting</a> (pdf) and <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="774cee16-0ae9-46fa-98f7-f946912ef2a8" href="/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500" title="Instructions for Completing Form FDA 3500">Instructions for Completing Form FDA 3500</a></strong><br> For use by healthcare professionals, consumers, and patients.</p> </div> </div> </div> <div title="MedWatch Forms for Patients and Consumers FDA Form 3500B pdf" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_6741488a96717"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6741488a96717" aria-controls="6741488a96717">MedWatch Forms for Patients and Consumers FDA Form 3500B pdf</a> </h2> </div> <div id="6741488a96717" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6741488a96717"> <div class="panel-body"> <p><strong><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5396cc92-6482-4f09-a7f4-d2f2fbb0e9c2" href="/media/85598/download?attachment" target title="MEDWATCH Consumer Voluntary Reporting (PDF)">Form FDA 3500B - Voluntary Reporting for Consumers</a></strong><br> A consumer-friendly version of the 3500 reporting form.</p> </div> </div> </div> <div title="MedWatch for Industry FDA Form 3500A pdf" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_6741488a967c9"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6741488a967c9" aria-controls="6741488a967c9">MedWatch for Industry FDA Form 3500A pdf</a> </h2> </div> <div id="6741488a967c9" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6741488a967c9"> <div class="panel-body"> <p><strong><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="dacecc84-a84f-41dc-955e-095b5d35be58" href="/media/69876/download?attachment" title="MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)">Form FDA 3500A - Mandatory Reporting</a></strong> and <a href="/media/133177/download"><strong>Instructions for Completing Form FDA 3500A</strong></a><br> Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel.</p> </div> </div> </div> <div title="MedWatch Online Reporting for Health Professionals, Patients and Consumers" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_6741488a9687f"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6741488a9687f" aria-controls="6741488a9687f">MedWatch Online Reporting for Health Professionals, Patients and Consumers</a> </h2> </div> <div id="6741488a9687f" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6741488a9687f"> <div class="panel-body"> <p><strong><a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home">Online Voluntary Reporting </a></strong><br> Easy online reporting with a by Health Professionals and Consumers and Patients.</p> </div> </div> </div> <div title="Denuncia Voluntaria del Consumer Formulario FDA 3500b" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_6741488a9691b"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#6741488a9691b" aria-controls="6741488a9691b">Denuncia Voluntaria del Consumer Formulario FDA 3500b</a> </h2> </div> <div id="6741488a9691b" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_6741488a9691b"> <div class="panel-body"> <p><strong><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="2f54fe10-a288-4ac1-badd-02c425d7b0b9" href="/media/122470/download?attachment" title="MEDWATCH Denuncia Voluntaria del Consumidor (PDF)">Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B</a> (En Español).</strong><br> Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo.</p> </div> </div> </div> </div> <hr> <h2>Where to Report Other FDA Regulated Product Safety Information</h2> <p>Other products that the FDA regulates include Tobacco Products, Vaccines, and Animal Drugs, Devices and Food, including Pet Food. These products utilize different reporting pathways. It is recommended that reports concerning these products be submitted directly to the appropriate portals below.</p> <ul> <li>Tobacco, E-cigarettes or Vaping: Report problems or adverse health events and tobacco product problems to include problems with e-cigarettes (also known as “vapes”), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus. Report issues to the <a href="https://www.safetyreporting.hhs.gov" target="_blank">Safety Reporting Portal</a>.</li> <li>Vaccines: Report vaccine events to the <a href="https://vaers.hhs.gov/reportevent.html">Vaccine Adverse Event Reporting System</a> (VAERS).</li> <li>Animal Drug, Device, Pet Food and Livestock Feed Problems: <a href="//www.fda.gov/vetproductreporting">Report a Problem</a> to the Center for Veterinary Medicine. </li> </ul> <p>Note that submissions for these products through MedWatch will be accepted and directed to the correct.</p> <h2>Resources For You</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="128b5d0f-4262-489d-9924-bd82e392212b" href="/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/about-medwatch-e-list" title="About the MedWatch E-list">Join MedWatch Alerts E-list</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1bd3cc27-2e12-4570-b46c-e4c68fecd22c" href="/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet" title="Reporting Unlawful Sales of Medical Products on the Internet">Reporting Unlawful Sales of Medical Products on the Internet</a></li> <li><a href="https://www.accessdata.fda.gov/scripts/MedWatchLearn/">MedWatchLearn</a></li> </ul> <br> <div class="field field--name-field-sub-topic-paragraphs field--type-entity-reference-revisions field--label-above"> <div class="field--label">Sub-Topic Paragraphs</div> <div class="field--items"> <div class="field--item"> <div class="paragraph paragraph--type--medwatch-safety-alerts paragraph--view-mode--default"> <section class="lcds-card-deck lcds-card-deck--horizontal txt-dark"> <div class="field field--name-field-title field--type-string field--label-hidden field--item"><div class="views-element-container form-group"><div class="view view-medwatch-safety-alerts view-id-medwatch_safety_alerts 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