510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

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<div class="lcds-toolbar text-center"> <a class="btn btn-primary" href="/media/85284/download">Download the Final Guidance Document</a> <a class="btn btn-primary" href="https://www.federalregister.gov/d/2024-27085">Read the Federal Register Notice</a> </div> <div class="lcds-statusbar text-center"> <span class="label label-default">Final</span> </div> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2F510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a 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role="main"> <div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">Docket Number:</dt> <dd class="cell-2_1"><a href="https://www.regulations.gov/docket/FDA-2016-D-2565">FDA-2016-D-2565</a></dd> <dt class="cell-1_2">Issued by:</dt> <dd class="cell-2_2"><a href="/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review"></a> <div class="field field--name-field-issuing-office-taxonomy field--type-entity-reference field--label-above"> <div class="field--label">Guidance Issuing Office</div> <div class="field--items"> <div class="field--item">Center for Devices and Radiological Health</div> </div> </div> </dd> </dl> </div> <p>This guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations. This guidance provides updated recommendations on the 510(k) Third Party Review Program and supersedes the "510(k) Third Party Review Program" guidance.</p> <div class="inset-column"> <hr> <h2>Submit Comments</h2> <div class="row"> <div class="col-xs-12 col-sm-4"> <a class="btn btn-primary" <a href="https://www.regulations.gov/docket/FDA-2016-D-2565/document">Submit Comments Online</a> </div> <div class="col-xs-12 col-sm-8"> <p class="lcds-explainer-txt">You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))</p> <p class="lcds-explainer-txt">If unable to submit comments online, please mail written comments to:</p> <p class="lcds-explainer-txt"> Dockets Management<br/> Food and Drug Administration<br/> 5630 Fishers Lane, Rm 1061<br/> Rockville, MD 20852</p> <p class="lcds-explainer-txt"> All written comments should be identified with this document's docket number: <a href="https://www.regulations.gov/docket/FDA-2016-D-2565">FDA-2016-D-2565</a>. 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510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review | FDA