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United States - Healthcare - FDA Finalizes New Rule For Lab-Developed Tests

United States - Healthcare - FDA Finalizes New Rule For Lab-Developed Tests
mondaq.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from mondaq.com Daily Mail and Mail on Sunday newspapers.

Audreym adamsColeenw hillVickig nortonDrug administrationLife sciencesFederal foodDevice amendmentsBeginning mayBeginning novemberMedical technologies industry

United States - Healthcare - FDA s New Rule Regulates Lab-Developed Tests Under FD&C Act

On April 29, 2024, the U.S. Food and Drug Administration announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests, including laboratory developed tests, are devices regulated under the Federal Food, Drug and Cosmetic Act.

Drug administrationFederal foodDevice amendmentsBeginning mayBeginning november

federalregister.gov - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from federalregister.gov Daily Mail and Mail on Sunday newspapers.

United statesGrand viewNew yorkStates pharmacopeiaPhelps mcnamaraD bruce burlingtonXavier becerraAlan mertzJeffreyn gibbsStephen chaLeslie kuxToby loweBrittany schuckRobertm califfC legal authorityTechnology association

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply To Laboratory Developed Tests - Healthcare

The Food and Drug Administration's (FDA) proposed rule would change decades of Laboratory Developed Test (LDT) regulation by expressly considering these in vitro diagnostics (IVDs) medical devices.

Foley hoagJeffrey shurenLaboratory developed testRadiological healthDrug administrationKey takeawaysDevice amendmentsHuman leukocyte antigenDirector jeffrey shurenFda publishes long awaited in vitro diagnostics proposed rule x2013 medical device regulations would apply to laboratory developed testsLife sciencesFood and drugs lawLife sciencesIotechnology amp nanotechnology

FDA Requirement of Class III Medical Device Case

In D’Addario v. Johnson and Johnson, the United States District Court for the District of New Jersey addressed express preemption principles in a product liability case involving Class III breast implants. The Court held the MDA expressly preempted state law claims.

United statesNew jerseyDaddario courtEthicon incUnited states district courtBell atlantic corpMentor worldwideUs supreme courtMedtronic incDevice amendmentsD addario courtDefendants johnsonConnecticut product liability actFirst amended complaintBell atlanticSecond amended complaint