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Jama Software is always looking for news that would benefit and inform our industry partners. As such, we\u2019ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from MedTech Dive<\/a>, titled \u201cFDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld\u201d<\/a> \u2013 originally authored by Nick Paul Taylor<\/a> and published on March 2, 2023.<\/p>\n Lawmakers have been trying to pass LDT legislation for years. An earlier form of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act was introduced<\/a> to Congress in 2018. Key aspects of the draft advanced as part of the FDA\u2019s user fee package last year, only to be cut<\/a> from the final version. A push to pass the VALID Act as standalone law fell short<\/a> late last year.<\/p>\n The FDA identified<\/a> a need to reconsider its policy of enforcement discretion for LDTs in 2010, reflecting the increasing complexity and risks of the tests, and shared a discussion paper in 2017. However, the paper is not enforceable.<\/p>\n Legislation would clarify the FDA\u2019s authority to regulate LDTs and give the agency new powers, but in the ongoing absence of action from Congress, work is now advancing under the current statutory authority. Hillebrenner, associate director for scientific and regulatory programs at the FDA\u2019s Center for Devices and Radiological Health, outlined<\/a> the situation at an American Clinical Laboratory Association event.<\/p>\n
\nFDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld<\/h2>\n
Dive Brief:<\/h3>\n
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\nRELATED: <\/strong>Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application \u2013 Part I<\/a><\/span><\/span><\/h4>\n
\nDive Insight:<\/h3>\n
\nRELATED: <\/strong>2023 Predictions for Medical Device Product Development<\/a><\/span><\/span><\/h4>\n
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