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Alert: FDA Announces Final Regulation Governing Laboratory Developed Tests

Holland & Knight sent this email to their subscribers on May 1, 2024.

Holland & Knight www.hklaw.com
 
 

May 1, 2024

 

FDA Announces Final Regulation Governing Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) announced in a long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices. Under medical device requirements, LDTs will be subject to premarket review, adverse event reporting, establishment registration and device listing, and other requirements.

​FDA plans to use a five-stage "phaseout policy" to transition currently marketed LDTs to regulated medical devices over the next four years.

Read the full article »

 

Contact the Authors

Sara M. Klock

Washington, D.C.
202.469.5465
[email protected]

Michael J. Werner

Washington, D.C.
202.419.2515
[email protected]


   


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Text-only version of this email

Holland & Knight www.hklaw.com MAY 1, 2024 FDA ANNOUNCES FINAL REGULATION GOVERNING LABORATORY DEVELOPED TESTS The U.S. Food and Drug Administration (FDA) announced in a long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices. Under medical device requirements, LDTs will be subject to premarket review, adverse event reporting, establishment registration and device listing, and other requirements. FDA plans to use a five-stage "phaseout policy" to transition currently marketed LDTs to regulated medical devices over the next four years. Read the full article » Contact the Authors SARA M. KLOCK Washington, D.C. 202.469.5465 [email protected] MICHAEL J. WERNER Washington, D.C. 202.419.2515 [email protected] More insights are available on our website. Connect With Us You are currently subscribed to receive Holland & Knight publications as . Your email address is never shared with any third parties. For more information about our privacy practices, please view the Holland & Knight Privacy Notice. To learn how to prevent these communications from [email protected] being intercepted by your spam filter, click here. Visit my subscription management to change your account preferences or . If this email was forwarded to you, and you would like to begin receiving this or any other Holland & Knight publication directly, please . The information provided herein presents general information and should not be relied on as legal advice when analyzing and resolving a specific legal issue. If you have specific questions regarding a particular fact situation, please consult with competent legal counsel about the facts and laws that apply. Copyright © 2024 Holland & Knight LLP All Rights Reserved Holland & Knight LLP | Operations Center | 524 Grand Regency Blvd. | Brandon, FL 33510-3931 | www.hklaw.com  
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