* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Monday, October 6, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    Charlie Hunnam Reflects on Playing a Serial Killer in Monster: The Ed Gein Story – Yahoo

    Charlie Hunnam Reveals the Dark Challenges of Playing a Serial Killer in Monster: The Ed Gein Story

    “Reba” cast, then and now: See the stars 24 years later (and who’s reunited for another show) – Yahoo

    “Reba” cast, then and now: See the stars 24 years later (and who’s reunited for another show) – Yahoo

    Why Taylor Swift Name-Dropped Elizabeth Taylor in Her New Album – Yahoo

    Here’s Why Taylor Swift Dropped Elizabeth Taylor’s Name in Her New Album

    Al Roker Gives Olivia Dean an Unexpected ‘New Job’ on the ‘Today’ Show – Yahoo

    Al Roker Shocks Olivia Dean with an Exciting New Role on the ‘Today’ Show

    Books about the arts and some haunts for a Denton October – Denton Record-Chronicle

    Uncover Artistic Treasures and Spooky Adventures to Experience in Denton This October

    Taylor Swift Releases New Album The Life of a Showgirl : Listen and Read the Full Credits – Yahoo

    Taylor Swift Releases New Album The Life of a Showgirl : Listen and Read the Full Credits – Yahoo

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Forget Cowbells. Cows Wear High-Tech Collars Now. – The New York Times

    Ditch the Cowbells: Discover the High-Tech Collars Transforming Cattle Care

    What the Recent Price Surge Means for Figure Technology Solutions After SEC Settlement – Yahoo Finance

    What the Recent Price Surge Reveals About Figure Technology Solutions Following SEC Settlement

    MAC Brings iPad Technology to Football Sidelines Across All 13 Member Schools – Sports Video Group

    MAC Brings iPad Technology to Football Sidelines Across All 13 Member Schools – Sports Video Group

    Technology Is Becoming More Important Than Humans In CX – No Jitter

    Technology Is Becoming More Important Than Humans In CX – No Jitter

    A Tech Expo Shows What China Can Make, but Not Who’ll Buy It All – The New York Times

    Inside China’s Tech Expo: Cutting-Edge Innovations Face Uncertain Demand

    Steampunk Metal Oval Technology Sense Sunglasses Personality Handmade Chain Multicolor Sunglasses UV400 – The San Joaquin Valley Sun

    Steampunk Metal Oval Sunglasses with Handmade Multicolor Chain – Bold UV400 Protection and Unique Style

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    Charlie Hunnam Reflects on Playing a Serial Killer in Monster: The Ed Gein Story – Yahoo

    Charlie Hunnam Reveals the Dark Challenges of Playing a Serial Killer in Monster: The Ed Gein Story

    “Reba” cast, then and now: See the stars 24 years later (and who’s reunited for another show) – Yahoo

    “Reba” cast, then and now: See the stars 24 years later (and who’s reunited for another show) – Yahoo

    Why Taylor Swift Name-Dropped Elizabeth Taylor in Her New Album – Yahoo

    Here’s Why Taylor Swift Dropped Elizabeth Taylor’s Name in Her New Album

    Al Roker Gives Olivia Dean an Unexpected ‘New Job’ on the ‘Today’ Show – Yahoo

    Al Roker Shocks Olivia Dean with an Exciting New Role on the ‘Today’ Show

    Books about the arts and some haunts for a Denton October – Denton Record-Chronicle

    Uncover Artistic Treasures and Spooky Adventures to Experience in Denton This October

    Taylor Swift Releases New Album The Life of a Showgirl : Listen and Read the Full Credits – Yahoo

    Taylor Swift Releases New Album The Life of a Showgirl : Listen and Read the Full Credits – Yahoo

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Forget Cowbells. Cows Wear High-Tech Collars Now. – The New York Times

    Ditch the Cowbells: Discover the High-Tech Collars Transforming Cattle Care

    What the Recent Price Surge Means for Figure Technology Solutions After SEC Settlement – Yahoo Finance

    What the Recent Price Surge Reveals About Figure Technology Solutions Following SEC Settlement

    MAC Brings iPad Technology to Football Sidelines Across All 13 Member Schools – Sports Video Group

    MAC Brings iPad Technology to Football Sidelines Across All 13 Member Schools – Sports Video Group

    Technology Is Becoming More Important Than Humans In CX – No Jitter

    Technology Is Becoming More Important Than Humans In CX – No Jitter

    A Tech Expo Shows What China Can Make, but Not Who’ll Buy It All – The New York Times

    Inside China’s Tech Expo: Cutting-Edge Innovations Face Uncertain Demand

    Steampunk Metal Oval Technology Sense Sunglasses Personality Handmade Chain Multicolor Sunglasses UV400 – The San Joaquin Valley Sun

    Steampunk Metal Oval Sunglasses with Handmade Multicolor Chain – Bold UV400 Protection and Unique Style

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

Lab Tests That Escape FDA Oversight May Come Under Agency Review

September 30, 2023
in Health
Lab Tests That Escape FDA Oversight May Come Under Agency Review
Share on FacebookShare on Twitter

The FDA issued its long-awaited proposal for regulating laboratory developed tests (LDTs) on Friday.

The proposed rule would amend FDA regulations to make explicit that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

The agency also wants to phase out its general enforcement discretion approach for laboratory-developed tests so IVDs manufactured by a lab would generally fall under the same approach as other IVDs.

LDTs are designed, manufactured, and used within a single clinical laboratory, which must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meet requirements to perform high complexity testing. Currently, LDTs are regulated by the Centers for Medicare & Medicaid Services, which does not require the tests to show clinical validity.

LDTs, like other IVDs, can be used to measure or detect substances, analytes, or markers like proteins, glucose, cholesterol, or DNA to help provide information about a patient’s health, including diagnosing, monitoring, or determining treatments. Recent LDTs have included a blood test to assess Alzheimer’s disease risk.

“These widely used tests are not generally coming to the FDA for review or otherwise complying with FDA requirements,” FDA Commissioner Robert Califf, MD, said in a news briefing. “This leaves Americans vulnerable to making important healthcare choices based on potentially faulty or inaccurate test results. This should not continue.”

“Laboratory developed tests play a central role in U.S. healthcare and many are similar to other tests that do come into the FDA for review,” Califf added. “This approach no longer makes sense and puts U.S. patients at risk.”

The proposed rule aims to help ensure the safety and effectiveness of LDTs, which are used in a growing number of healthcare decisions, the FDA said.

“Patients cannot be assured their tests provide accurate results,” Jeff Shuren, MD, JD, director of the FDA’s Center for Device and Radiological Health, said in the briefing. “The FDA currently oversees tests made by non-laboratory manufacturers but is not generally overseeing tests made by laboratories.”

Modern LDTs carry greater risks than ones used decades ago, he noted. In the 1970s, LDTs were “mostly low risk, manufactured in smaller volumes, and used for the specialized needs of a local patient population,” Shuren said.

“However, the LDT market looks drastically different today than it did roughly 50 years ago,” he pointed out. “The complexity and volume of these tests have evolved dramatically,” with LDTs increasingly relying on high-tech instrumentation and software, being performed in large volumes, and being vulnerable to cyber-security risks.

The FDA expressed concern that patients could initiate unnecessary treatment, or delay or forego proper treatment based on inaccurate LDT results. “For example, the FDA is aware of IVDs offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism, and Alzheimer’s disease,” the agency said.

After the rule is finalized, the FDA would gradually phase out its previous enforcement approach, the agency said. The agency also discussed alternatives for some LDTs, including a different approach for academic medical center laboratories.

The American Clinical Laboratory Association (ACLA), the national trade association representing labs like Quest Diagnostics and LabCorp, issued a statement Friday that it “does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system.”

“ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the Agency’s current authority,” the group said. “LDTs are not medical devices.”

But other groups expressed support for the FDA’s proposal. “This rule is a critical step forward for clinical medicine,” Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest and former FDA associate commissioner, said in a statement.

“It will help ensure that when a patient receives a test, they can rely on the results to make essential decisions for their health,” Lurie said. “This rule will close a gaping hole in FDA’s current regulatory reach.”

Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/washington-watch/fdageneral/106575

Tags: EscapehealthTests
Previous Post

Fezolinetant Benefits Women Not Suited for Hormone Therapy

Next Post

Are Obesity Drugs for Adolescents Cost-Effective?

Air quality speed run – Washington State Department of Ecology (.gov)

Battling Pollution: Washington State’s Urgent Fight for Cleaner Air

October 6, 2025
Equity in science is a beautiful lie — and I’m done pretending – Nature

Equity in science is a beautiful lie — and I’m done pretending – Nature

October 6, 2025
Explore a bird database with 11,500 species – Popular Science

Explore an Incredible Bird Database Showcasing 11,500 Stunning Species

October 6, 2025
South Shore broker funded ‘extravagant lifestyle’ with $11.6 million taken from clients and colleagues, prosecutors say – Boston.com

South Shore broker funded ‘extravagant lifestyle’ with $11.6 million taken from clients and colleagues, prosecutors say – Boston.com

October 6, 2025
QRG Capital Management Inc. Purchases 9,519 Shares of Marvell Technology, Inc. $MRVL – MarketBeat

QRG Capital Management Takes Bold Step by Acquiring 9,519 Shares of Marvell Technology

October 6, 2025
Jaxson Dart, Cam Skattebo fumble away a Giant opportunity vs. Saints – Yahoo Sports

Jaxson Dart, Cam Skattebo fumble away a Giant opportunity vs. Saints – Yahoo Sports

October 6, 2025
‘The World Report’ of The Church of Jesus Christ of Latter-day Saints – KSL TV 5

Inside The World Report: Exploring the Impact of The Church of Jesus Christ of Latter-day Saints

October 6, 2025
Thai Airways Launches New Premium Economy on Flights From Most Visited City in the World – Aviation A2Z

Thai Airways Launches New Premium Economy on Flights From Most Visited City in the World – Aviation A2Z

October 6, 2025
Charlie Hunnam Reflects on Playing a Serial Killer in Monster: The Ed Gein Story – Yahoo

Charlie Hunnam Reveals the Dark Challenges of Playing a Serial Killer in Monster: The Ed Gein Story

October 6, 2025
Pre-rolls, education and industry optimism: Takeaways from Ohio Cannabis Health & Business Summit 2025 – Cleveland.com

Pre-rolls, Education, and Industry Optimism: Top Insights from the Ohio Cannabis Health & Business Summit 2025

October 6, 2025

Categories

Archives

October 2025
M T W T F S S
 12345
6789101112
13141516171819
20212223242526
2728293031  
« Sep    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (854)
  • Economy (874)
  • Entertainment (21,748)
  • General (17,441)
  • Health (9,916)
  • Lifestyle (887)
  • News (22,149)
  • People (876)
  • Politics (885)
  • Science (16,085)
  • Sports (21,375)
  • Technology (15,855)
  • World (857)

Recent News

Air quality speed run – Washington State Department of Ecology (.gov)

Battling Pollution: Washington State’s Urgent Fight for Cleaner Air

October 6, 2025
Equity in science is a beautiful lie — and I’m done pretending – Nature

Equity in science is a beautiful lie — and I’m done pretending – Nature

October 6, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version