--- title: "Laboratory Developed Tests: Issues and Anticipated Regulations" description: "webinar: Laboratory Developed Tests: Issues and Anticipated Regulations - the shift from manufacturer-based oversight to the new risk-based approach for LDTs." --- ![footer-logo.png](https://www.thefdagroup.com/hs-fs/hubfs/thefdagroup-header-image/lp-logo.png?width=123&name=lp-logo.png "footer-logo.png") ## Watch our free webinar: Laboratory Developed Tests: Issues and Anticipated Regulations What you need to know about the shift from manufacturer-based oversight to the new risk-based approach for LDTs. Since 2014, the FDA has been adopting a risk-based approach to regulatory oversight for LDTs which replaced the older system which focused on the type of manufacturer or laboratory involved. In this Webinar, instructor Larry Stevens, RAC, will walk you through this new risk-based approach in detail, giving you all the information you need to anticipate the new regulations. You’ll learn: - How the new regulatory approach differs from the old one - An overview of relevant draft guidances issued by the FDA - Answers to common questions regarding LDTs and their regulatory requirements ### ****45-minute presentation with 15 minutes of Q&A.**** #### Share [![Share on Facebook](https://static.hubspot.com/final/img/common/icons/social/facebook-24x24.png)](http://www.facebook.com/share.php?u=https%3A%2F%2Fwww.thefdagroup.com%2Flaboratory-developed-tests-issues-and-anticipated-regulations%3Futm_medium%3Dsocial%26utm_source%3Dfacebook) [![Share on LinkedIn](https://static.hubspot.com/final/img/common/icons/social/linkedin-24x24.png)](http://www.linkedin.com/shareArticle?mini=true&url=https%3A%2F%2Fwww.thefdagroup.com%2Flaboratory-developed-tests-issues-and-anticipated-regulations%3Futm_medium%3Dsocial%26utm_source%3Dlinkedin) [![Share on Twitter](https://static.hubspot.com/final/img/common/icons/social/twitter-24x24.png)](https://twitter.com/intent/tweet?original_referer=https%3A%2F%2Fwww.thefdagroup.com%2Flaboratory-developed-tests-issues-and-anticipated-regulations%3Futm_medium%3Dsocial%26utm_source%3Dtwitter&url=https%3A%2F%2Fwww.thefdagroup.com%2Flaboratory-developed-tests-issues-and-anticipated-regulations%3Futm_medium%3Dsocial%26utm_source%3Dtwitter&source=tweetbutton&text=Laboratory%20Developed%20Tests%3A%20Issues%20and%20Anticipated%20Regulations) [![Share on Email](https://static.hubspot.com/final/img/common/icons/social/email-24x24.png)](mailto:?subject=Check%20out%20https%3A%2F%2Fwww.thefdagroup.com%2Flaboratory-developed-tests-issues-and-anticipated-regulations%3Futm_medium%3Dsocial%26utm_source%3Demail%20&body=Check%20out%20https%3A%2F%2Fwww.thefdagroup.com%2Flaboratory-developed-tests-issues-and-anticipated-regulations%3Futm_medium%3Dsocial%26utm_source%3Demail) ### Listen to the Webinar ![footer-logo.png](https://www.thefdagroup.com/hs-fs/hubfs/thefdagroup-footer-image/footer-logo.png?width=187&name=footer-logo.png "footer-logo.png") ### Contact Info 68 Harrison Ave Ste 605 PMB 490101 Boston, Massachusetts 02111 (508) 926-8330 [info@thefdagroup.com](mailto:info@thefdagroup.com) [![in.png](https://www.thefdagroup.com/hs-fs/hubfs/thefdagroup-footer-image/in.png?width=19&height=19&name=in.png "in.png")Follow us on Linkedln](https://www.linkedin.com/company/the-fda-group) [![in.png](https://www.thefdagroup.com/hs-fs/hubfs/thefdagroup-footer-image/TWT.png?width=19&height=19&name=TWT.png "in.png")Follow us on Twitter](https://twitter.com/thefdagroup) [![in.png](https://www.thefdagroup.com/hs-fs/hubfs/thefdagroup-footer-image/book-icon.png?width=19&height=19&name=book-icon.png "in.png")Download our brochure](https://www.thefdagroup.com/hubfs/Downloads/The-FDA-Group-GxP-Auditing-Remediation-Staff-Augmentation-Brochure.pdf) ![FDAgroup_logo-150x150.png](https://www.thefdagroup.com/hs-fs/hubfs/Images/FDAgroup_logo-150x150.png?width=150&name=FDAgroup_logo-150x150.png "FDAgroup_logo-150x150.png") Proprietary talent selection of former FDA and industry professionals amplified by a corporate culture of responsiveness and execution. ### Contact Info 68 Harrison Ave Ste 605 PMB 490101 Boston, Massachusetts 02111 US Toll-Free: 1-833-FDA-GROUP International: +001 508 926 8330 [info@thefdagroup.com](mailto:info@thefdagroup.com) [![footer-linkedin](https://www.thefdagroup.com/hubfs/thefdagroup-footer-image/footer-linkedin.svg "footer-linkedin")Follow us on Linkedln](https://www.linkedin.com/company/the-fda-group) [![footer-twitter](https://www.thefdagroup.com/hubfs/thefdagroup-footer-image/footer-twitter.svg "footer-twitter")Follow us on Twitter](https://twitter.com/thefdagroup) [![footer-brochure](https://www.thefdagroup.com/hubfs/thefdagroup-footer-image/footer-brochure.svg "footer-brochure")Download our brochure](https://www.thefdagroup.com/hubfs/Downloads/The-FDA-Group-GxP-Auditing-Remediation-Staff-Augmentation-Brochure.pdf) The FDA Group will not be liable for any errors or omissions in this information nor for the availability of this information. 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