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FDA Yields To Pressure, Delays ‘Intended Use’ Rule

 
• By Elizabeth Orr

The agency has granted a petition from trade groups to delay controversial revisions to its definition of “intended use” for at least one year, and is also gathering comments to guide possible further revisions.

FDA has delayed implementation of proposed changes to its definition of “intended use” by one year in the face of significant stakeholder protest.

A final rule published Jan. 9 would have broadened the definition of “intended use” to what is called the “totality...

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UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
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Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

More from Policy & Regulation

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

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