</ iframe></noscript> <!-- End Google Tag Manager (noscript) --> <div id="page" class="site"><a aria-label="skip to content" class="skip-link" href="#content">Skip to Content</a> <header class="site-header header-layout-three header-layout-seven header-layout-eight" itemscope itemtype="http://schema.org/WPHeader"> <div class="header-holder"> <div class="header-m" style="background-image:url(https://ddblog.labcorp.com/wp-content/uploads/2021/07/blog-header-1.png)"> <div class="container"> <div class="site-branding" itemscope itemtype="http://schema.org/Organization"> <p class="site-title" itemprop="name"><a href="https://ddblog.labcorp.com/" rel="home" itemprop="url">Insights From Our Labs to Yours</a></p> <p class="site-description" itemprop="description">Labcorp Drug Development Blog</p> </div> </div> </div> </div> <div class="sticky-holder"></div> <div class="header-b"> <div class="container"> <button aria-label="primary menu toggle" id="primary-toggle-button"><i class="fa fa-bars"></i>Navigation</button> <nav id="site-navigation" class="main-navigation" itemscope itemtype="http://schema.org/SiteNavigationElement"> <div class="menu-main-container"><ul id="primary-menu" class="menu"><li id="menu-item-6077" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-home menu-item-6077"><a href="https://ddblog.labcorp.com">Home</a></li> <li id="menu-item-5821" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-has-children menu-item-5821"><a href="https://ddblog.labcorp.com/industry/">Industry</a> <ul class="sub-menu"> <li id="menu-item-5824" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5824"><a href="https://ddblog.labcorp.com/industry/device/">Device</a></li> <li id="menu-item-5825" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5825"><a href="https://ddblog.labcorp.com/industry/drug-development/">Drug</a></li> <li id="menu-item-5822" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5822"><a href="https://ddblog.labcorp.com/industry/chemical/">Chemical</a></li> <li id="menu-item-5823" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5823"><a href="https://ddblog.labcorp.com/industry/crop/">Crop</a></li> </ul> </li> <li id="menu-item-5828" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-has-children menu-item-5828"><a href="https://ddblog.labcorp.com/phase/">Phase</a> <ul class="sub-menu"> <li id="menu-item-5829" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5829"><a href="https://ddblog.labcorp.com/phase/discovery/">Discovery</a></li> <li id="menu-item-5835" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5835"><a href="https://ddblog.labcorp.com/phase/preclinical-nonclinical/">Preclinical/Nonclinical</a></li> <li id="menu-item-5831" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5831"><a href="https://ddblog.labcorp.com/phase/phase-i-iia/">Phase I-IIa</a></li> <li id="menu-item-5832" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5832"><a href="https://ddblog.labcorp.com/phase/phase-iib-iii/">Phase IIb-III</a></li> <li id="menu-item-5833" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5833"><a href="https://ddblog.labcorp.com/phase/pilot/">Pilot</a></li> <li id="menu-item-5834" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5834"><a href="https://ddblog.labcorp.com/phase/pivotal/">Pivotal</a></li> <li id="menu-item-5830" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5830"><a href="https://ddblog.labcorp.com/phase/formulation-packaging/">Formulation, Packaging, etc.</a></li> </ul> </li> <li id="menu-item-5836" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-has-children menu-item-5836"><a href="https://ddblog.labcorp.com/molecule-type/">Molecule Type</a> <ul class="sub-menu"> <li id="menu-item-5837" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5837"><a href="https://ddblog.labcorp.com/molecule-type/biologics/">Biologics</a></li> <li id="menu-item-5841" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5841"><a href="https://ddblog.labcorp.com/molecule-type/small-molecules/">Small Molecules</a></li> <li id="menu-item-5839" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5839"><a href="https://ddblog.labcorp.com/molecule-type/biosimilars/">Biosimilars</a></li> <li id="menu-item-5838" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5838"><a href="https://ddblog.labcorp.com/molecule-type/biomarkers/">Biomarkers</a></li> <li id="menu-item-5840" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5840"><a href="https://ddblog.labcorp.com/molecule-type/cell-gene-therapies/">Cell/Gene Therapies</a></li> </ul> </li> <li id="menu-item-5844" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-has-children menu-item-5844"><a href="https://ddblog.labcorp.com/data-informatics/">Data/Informatics</a> <ul class="sub-menu"> <li id="menu-item-5842" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5842"><a href="https://ddblog.labcorp.com/data-informatics/send/">SEND</a></li> <li id="menu-item-5845" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5845"><a href="https://ddblog.labcorp.com/data-informatics/modeling/">Modeling</a></li> <li id="menu-item-5846" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5846"><a href="https://ddblog.labcorp.com/data-informatics/patient-recruitment/">Patient Recruitment</a></li> <li id="menu-item-5843" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5843"><a href="https://ddblog.labcorp.com/data-informatics/xcellerate/">Xcellerate</a></li> </ul> </li> <li id="menu-item-5827" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-has-children menu-item-5827"><a href="https://ddblog.labcorp.com/about-covance/">About Us</a> <ul class="sub-menu"> <li id="menu-item-5704" class="menu-item menu-item-type-taxonomy menu-item-object-category menu-item-5704"><a href="https://ddblog.labcorp.com/about-covance/careers-and-culture/">Careers and Culture</a></li> <li id="menu-item-5792" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-5792"><a href="http://response.covance.com/contact-us?elqCampaignId=399&cid=Web_Clk_CVD_blog_megamenunav_0615_399">Contact Us</a></li> <li id="menu-item-5791" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-5791"><a href="https://drugdevelopment.labcorp.com">Labcorp Drug Development</a></li> </ul> </li> </ul></div> </nav><!-- #site-navigation --> <div class="right"> <div class="tools"> <div class="form-section"> <button aria-label="search form toggle" id="btn-search"><i class="fa fa-search"></i></button> <div class="form-holder"> <form role="search" method="get" class="search-form" action="https://ddblog.labcorp.com/"> <label> <span class="screen-reader-text">Search for:</span> <input type="search" class="search-field" placeholder="Search …" value="" name="s" /> </label> <input type="submit" class="search-submit" value="Search" /> </form> </div> </div> </div> <ul class="social-networks"> <li><a href="https://www.linkedin.com/company/labcorpdrugdevelopment" target="_blank" rel="nofollow"><i class="fab fa-linkedin"></i></a></li> <li><a href="https://twitter.com/LabcorpDrugDev" target="_blank" rel="nofollow"><i class="fab fa-twitter-square"></i></a></li> <li><a href="https://www.facebook.com/LabcorpDrugDevelopment" target="_blank" rel="nofollow"><i class="fab fa-facebook"></i></a></li> </ul> </div> </div> </div> </header> <div class="top-bar"> <div class="container"> <header class="page-header"> <h1 class="page-title">Clinical Testing</h1> </header><!-- .page-header --> <div class="breadcrumb-wrapper"> <div id="crumbs" itemscope itemtype="http://schema.org/BreadcrumbList"> <span itemprop="itemListElement" itemscope itemtype="http://schema.org/ListItem"> <a itemprop="item" href="https://ddblog.labcorp.com"><span itemprop="name">Home</span></a> <meta itemprop="position" content="1" /> <span class="separator">/</span> </span><span class="current" itemprop="itemListElement" itemscope itemtype="http://schema.org/ListItem"><a itemprop="item" href="https://ddblog.labcorp.com/tag/clinical-testing/"><span itemprop="name">Clinical Testing</span></a><meta itemprop="position" content="2" /></span></div></div><!-- .breadcrumb-wrapper --> </div> </div> <div class="container main-content"> <div id="content" class="site-content"> <div class="row"> <div id="primary" class="content-area"> <main id="main" class="site-main"> <div class="row"> <article id="post-3262" class="post-3262 post type-post status-publish format-standard has-post-thumbnail hentry category-central-laboratory-services tag-central-laboratory-services-2 tag-china tag-clinical-testing tag-inspections tag-regulatory latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2017/07/covance-central-laboratory-services-shanghai/" class="post-thumbnail"><img width="448" height="300" src="https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="" srcset="https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility.jpg 1494w, https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility-300x201.jpg 300w, https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility-768x514.jpg 768w, https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility-1024x685.jpg 1024w, https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility-448x300.jpg 448w" sizes="(max-width: 448px) 100vw, 448px" data-attachment-id="5500" data-permalink="https://ddblog.labcorp.com/covance-china-shanghai-facility-2/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility.jpg" data-orig-size="1494,1000" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"0"}" data-image-title="" data-image-description="" data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility-300x201.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2019/01/Covance-China-Shanghai-facility-1024x685.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://ddblog.labcorp.com/2017/07/covance-central-laboratory-services-shanghai/&title=Central%20Laboratory%20Services%20in%20Shanghai%20Helps%20Clients%20Navigate%20Chinese%20Regulatory%20Reform" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=Central%20Laboratory%20Services%20in%20Shanghai%20Helps%20Clients%20Navigate%20Chinese%20Regulatory%20Reform https://ddblog.labcorp.com/2017/07/covance-central-laboratory-services-shanghai/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://ddblog.labcorp.com/2017/07/covance-central-laboratory-services-shanghai/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#251a7650474f4046511866404b515744490017156944474a5744514a575c001715764057534c4640560017154c4b001715764d444b424d444c0017156d4049555600171566494c404b51560017156b44534c42445140001715664d4c4b405640001715774042504944514a575c0017157740434a5748030615161d1e674a415c184d515155561f0a0a414147494a420b494447464a57550b464a480a171514120a15120a464a53444b46400846404b51574449084944474a5744514a575c08564057534c46405608564d444b424d444c0a" rel="nofollow" target="_blank"><i class="fa fa-envelope" aria-hidden="true"></i></a></li> </ul> </div> </div> </div><h2 class="entry-title" itemprop="headline"><a href="https://ddblog.labcorp.com/2017/07/covance-central-laboratory-services-shanghai/" rel="bookmark">Central Laboratory Services in Shanghai Helps Clients Navigate Chinese Regulatory Reform</a></h2><div class="entry-meta"><span class="byline" itemprop="author" itemscope itemtype="https://schema.org/Person"> by <span class="author vcard" itemprop="name"><a class="url fn n" href="https://ddblog.labcorp.com/author/covance/">Labcorp Drug Development</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2017/07/covance-central-laboratory-services-shanghai/" rel="bookmark"><time class="entry-date published updated" datetime="2021-05-19T13:52:35-04:00" itemprop="dateModified">Wednesday, May 19, 2021</time><time class="updated" datetime="2017-07-19T12:17:40-04:00" itemprop="datePublished">Wednesday, July 19, 2017</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China. As a continued commitment to meet clients’ needs and conform to local Chinese … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-3262 --> <article id="post-3172" class="post-3172 post type-post status-publish format-standard has-post-thumbnail hentry category-central-laboratory-services category-drug-development category-phase-iib-iii category-small-molecules category-vaccine tag-biologics tag-biomarkers tag-clinical-testing tag-elispot tag-vaccines latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2017/06/benefits-of-elispot-assays/" class="post-thumbnail"><img width="450" height="150" src="https://ddblog.labcorp.com/wp-content/uploads/2014/08/ELISPOT.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="" srcset="https://ddblog.labcorp.com/wp-content/uploads/2014/08/ELISPOT.jpg 500w, https://ddblog.labcorp.com/wp-content/uploads/2014/08/ELISPOT-300x100.jpg 300w" sizes="(max-width: 450px) 100vw, 450px" data-attachment-id="1859" data-permalink="https://ddblog.labcorp.com/elispot-2/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2014/08/ELISPOT.jpg" data-orig-size="500,167" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":""}" data-image-title="" data-image-description="" data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2014/08/ELISPOT-300x100.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2014/08/ELISPOT.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://ddblog.labcorp.com/2017/06/benefits-of-elispot-assays/&title=ELISPOT%20Assay:%20A%20Powerful%20Tool%20in%20Vaccine%20Development%20and%20Immune%20Monitoring" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=ELISPOT%20Assay:%20A%20Powerful%20Tool%20in%20Vaccine%20Development%20and%20Immune%20Monitoring https://ddblog.labcorp.com/2017/06/benefits-of-elispot-assays/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://ddblog.labcorp.com/2017/06/benefits-of-elispot-assays/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#be81edcbdcd4dbddca83fbf2f7edeef1ea9b8c8effcdcddfc7849b8c8eff9b8c8eeed1c9dbccd8cbd29b8c8eead1d1d29b8c8ed7d09b8c8ee8dfddddd7d0db9b8c8efadbc8dbd2d1ced3dbd0ca9b8c8edfd0da9b8c8ef7d3d3cbd0db9b8c8ef3d1d0d7cad1ccd7d0d9989d8e8d8685fcd1dac783d6cacacecd849191dadadcd2d1d990d2dfdcddd1ccce90ddd1d3918c8e8f89918e8891dcdbd0dbd8d7cacd93d1d893dbd2d7cdced1ca93dfcdcddfc7cd91" rel="nofollow" target="_blank"><i class="fa fa-envelope" aria-hidden="true"></i></a></li> </ul> </div> </div> </div><h2 class="entry-title" itemprop="headline"><a href="https://ddblog.labcorp.com/2017/06/benefits-of-elispot-assays/" rel="bookmark">ELISPOT Assay: A Powerful Tool in Vaccine Development and Immune Monitoring</a></h2><div class="entry-meta"><span class="byline" itemprop="author" itemscope itemtype="https://schema.org/Person"> by <span class="author vcard" itemprop="name"><a class="url fn n" href="https://ddblog.labcorp.com/author/sinnathamby-gomathinayagam/">Sinnathamby Gomathinayagam, Ph.D.</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2017/06/benefits-of-elispot-assays/" rel="bookmark"><time class="entry-date published updated" datetime="2021-05-20T09:19:27-04:00" itemprop="dateModified">Thursday, May 20, 2021</time><time class="updated" datetime="2017-06-01T09:27:49-04:00" itemprop="datePublished">Thursday, June 1, 2017</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-3172 --> <article id="post-2809" class="post-2809 post type-post status-publish format-standard has-post-thumbnail hentry category-central-laboratory-services tag-clinical-testing tag-fda tag-mhealth tag-mobile-health latest_post" itemscope itemtype="https://schema.org/Blog"> <a href="https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/" class="post-thumbnail"><img width="209" height="300" src="https://ddblog.labcorp.com/wp-content/uploads/2016/06/Covance-Mobile-Health-Blog.jpg" class="attachment-blossom-feminine-cat size-blossom-feminine-cat wp-post-image" alt="Covance Mobile Health Blog" srcset="https://ddblog.labcorp.com/wp-content/uploads/2016/06/Covance-Mobile-Health-Blog.jpg 500w, https://ddblog.labcorp.com/wp-content/uploads/2016/06/Covance-Mobile-Health-Blog-209x300.jpg 209w" sizes="(max-width: 209px) 100vw, 209px" data-attachment-id="2814" data-permalink="https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/covance-mobile-health-blog/" data-orig-file="https://ddblog.labcorp.com/wp-content/uploads/2016/06/Covance-Mobile-Health-Blog.jpg" data-orig-size="500,718" data-comments-opened="0" data-image-meta="{"aperture":"0","credit":"","camera":"","caption":"","created_timestamp":"0","copyright":"","focal_length":"0","iso":"0","shutter_speed":"0","title":"","orientation":"1"}" data-image-title="Covance Mobile Health Blog" data-image-description="<p>Covance Mobile Health Blog</p> " data-medium-file="https://ddblog.labcorp.com/wp-content/uploads/2016/06/Covance-Mobile-Health-Blog-209x300.jpg" data-large-file="https://ddblog.labcorp.com/wp-content/uploads/2016/06/Covance-Mobile-Health-Blog.jpg" /></a> <div class="text-holder"> <header class="entry-header"> <div class="top"> <div class="share"> <i class="fa fa-share-alt"></i>Share <div class="social-networks"> <ul> <li><a href="https://www.linkedin.com/shareArticle?mini=true&url=https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/&title=Developing%20a%20Successful%20Regulatory%20Strategy%20for%20Mobile%20Health%20Devices%20and%20Applications" rel="nofollow" target="_blank"><i class="fa fa-linkedin" aria-hidden="true"></i></a></li><li><a href="https://twitter.com/home?status=Developing%20a%20Successful%20Regulatory%20Strategy%20for%20Mobile%20Health%20Devices%20and%20Applications https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/" rel="nofollow" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li><li><a href="https://www.facebook.com/sharer/sharer.php?u=https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/" rel="nofollow" target="_blank"><i class="fa fa-facebook" aria-hidden="true"></i></a></li><li><a href="/cdn-cgi/l/email-protection#e7d8b492858d828493daa38291828b88978e8980c2d5d786c2d5d7b492848482949481928bc2d5d7b58280928b869388959ec2d5d7b49395869382809ec2d5d7818895c2d5d7aa88858e8b82c2d5d7af82868b938fc2d5d7a382918e848294c2d5d7868983c2d5d7a697978b8e8486938e888994c1c4d7d4dfdca588839eda8f93939794ddc8c88383858b8880c98b868584889597c984888ac8d5d7d6d1c8d7d1c8838291828b88978e8980ca9492848482949481928bca958280928b869388959eca949395869382809eca8a88858e8b82ca8f82868b938fca8382918e848294ca8697978b8e8486938e888994c8" rel="nofollow" target="_blank"><i class="fa fa-envelope" aria-hidden="true"></i></a></li> </ul> </div> </div> </div><h2 class="entry-title" itemprop="headline"><a href="https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/" rel="bookmark">Developing a Successful Regulatory Strategy for Mobile Health Devices and Applications</a></h2><div class="entry-meta"><span class="byline" itemprop="author" itemscope itemtype="https://schema.org/Person"> by <span class="author vcard" itemprop="name"><a class="url fn n" href="https://ddblog.labcorp.com/author/bhanlon-and-sthiel/">Bill Hanlon, PhD & Scott Thiel, MBA, MT (ASCP)</a></span></span><span class="posted-on"><span class="text-on">updated on </span><a href="https://ddblog.labcorp.com/2016/06/developing-successful-regulatory-strategy-mobile-health-devices-applications/" rel="bookmark"><time class="entry-date published updated" datetime="2021-05-19T12:56:53-04:00" itemprop="dateModified">Wednesday, May 19, 2021</time><time class="updated" datetime="2016-06-22T14:44:15-04:00" itemprop="datePublished">Wednesday, June 22, 2016</time></a></span></div><!-- .entry-meta --> </header><!-- .entry-header home--> <div class="entry-content" itemprop="text"> <p>For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The guidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas. To make progress in this rapidly changing field, … </p> </div><!-- .entry-content --> <footer class="entry-footer"> </footer><!-- .entry-footer home--> </div><!-- .text-holder --> </article><!-- #post-2809 --> </div> <div class="pagination"></div> </main><!-- #main --> </div><!-- #primary --> </div><!-- .row/not-found --> </div><!-- #content --> </div><!-- .container/.main-content --> <footer id="colophon" class="site-footer" itemscope itemtype="http://schema.org/WPFooter"> <div class="site-info"> <div class="container"> <span class="copyright">Copyright © 2022 Labcorp All rights reserved.</span> </div> </div> </footer><!-- #colophon --> <button aria-label="go to top" id="blossom-top"> <span><i class="fa fa-angle-up"></i>TOP</span> </button> </div><!-- #page --> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/all.min.js?ver=5.6.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/v4-shims.min.js?ver=5.6.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/sticky-kit.min.js?ver=1.1.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/owl.carousel.min.js?ver=2.2.1'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/owl.carousel.aria.min.js?ver=2.0.0'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/jquery.matchHeight.min.js?ver=0.7.2'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/wow.min.js?ver=1.1.3'></script> <script type='text/javascript'> /* <![CDATA[ */ var bfp_data = {"lightbox":"","auto":"","loop":"","speed":"3000","animation":"fadeOut","child":"default","sticky":"","sticky_widget":"","header":"eight","url":"https:\/\/ddblog.labcorp.com\/wp-admin\/admin-ajax.php","rtl":""}; /* ]]> */ </script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/custom.min.js?ver=2.3.3'></script> <script type='text/javascript'> /* <![CDATA[ */ var bfp_ajax = {"url":"https:\/\/ddblog.labcorp.com\/wp-admin\/admin-ajax.php","startPage":"1","maxPages":"1","nextLink":null,"autoLoad":"load_more","loadmore":"Load More Posts","loading":"Loading...","nomore":"No More Post","layouts":"two-col-right","plugin_url":"https:\/\/ddblog.labcorp.com\/wp-content\/plugins"}; /* ]]> */ </script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/themes/blossom-feminine-pro/js/ajax.min.js?ver=2.3.3'></script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-includes/js/wp-embed.min.js?ver=5.4'></script> <script type='text/javascript'> /* <![CDATA[ */ var jetpackCarouselStrings = {"widths":[370,700,1000,1200,1400,2000],"is_logged_in":"","lang":"en","ajaxurl":"https:\/\/ddblog.labcorp.com\/wp-admin\/admin-ajax.php","nonce":"ab30097374","display_exif":"1","display_comments":"1","display_geo":"1","single_image_gallery":"1","single_image_gallery_media_file":"","background_color":"black","comment":"Comment","post_comment":"Post Comment","write_comment":"Write a Comment...","loading_comments":"Loading Comments...","download_original":"View full size <span class=\"photo-size\">{0}<span class=\"photo-size-times\">\u00d7<\/span>{1}<\/span>","no_comment_text":"Please be sure to submit some text with your comment.","no_comment_email":"Please provide an email address to comment.","no_comment_author":"Please provide your name to comment.","comment_post_error":"Sorry, but there was an error posting your comment. Please try again later.","comment_approved":"Your comment was approved.","comment_unapproved":"Your comment is in moderation.","camera":"Camera","aperture":"Aperture","shutter_speed":"Shutter Speed","focal_length":"Focal Length","copyright":"Copyright","comment_registration":"1","require_name_email":"1","login_url":"https:\/\/ddblog.labcorp.com\/wp-login.php?redirect_to=https%3A%2F%2Fddblog.labcorp.com%2F2016%2F06%2Fdeveloping-successful-regulatory-strategy-mobile-health-devices-applications%2F","blog_id":"1","meta_data":["camera","aperture","shutter_speed","focal_length","copyright"],"local_comments_commenting_as":"<p id=\"jp-carousel-commenting-as\">You must be <a href=\"#\" class=\"jp-carousel-comment-login\">logged in<\/a> to post a comment.<\/p>"}; /* ]]> */ </script> <script type='text/javascript' src='https://ddblog.labcorp.com/wp-content/plugins/jetpack/_inc/build/carousel/jetpack-carousel.min.js?ver=9.1.1'></script> <script type="text/javascript"> if(typeof _satellite !== "undefined"){ _satellite.pageBottom(); } </script> </body> </html>