- FDA targets more oversight of lab|made tests🔍
- FDA brings lab tests under federal oversight in bid to improve ...🔍
- FDA Takes Action Aimed at Helping to Ensure the Safety and ...🔍
- FDA Finalizes Rule and Sets Course to Phase In Oversight of ...🔍
- FDA brings lab tests under federal oversight🔍
- 5 steps to navigate the FDA's new lab developed test rule🔍
- FDA Brings Lab Tests Under Federal Oversight in Bid to Improve ...🔍
- The FDA's Proposed Ruling on Lab Tests Could Have Unintended ...🔍
FDA targets more oversight of lab|made tests
FDA targets more oversight of lab-made tests - Axios
The Food and Drug Administration on Friday rolled out a plan to regulate lab-developed tests that have long escaped close agency scrutiny.
FDA brings lab tests under federal oversight in bid to improve ... - PBS
The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories, a ...
FDA Takes Action Aimed at Helping to Ensure the Safety and ...
Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed ...
FDA Finalizes Rule and Sets Course to Phase In Oversight of ...
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory ...
FDA brings lab tests under federal oversight | AP News
The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories.
5 steps to navigate the FDA's new lab developed test rule
In a major shift, most tests designed by individual labs for in-house use must meet Food and Drug Administration requirements for medical ...
FDA Brings Lab Tests Under Federal Oversight in Bid to Improve ...
Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be ...
The FDA's Proposed Ruling on Lab Tests Could Have Unintended ...
Yale experts are raising concerns about a rule proposed by the U.S. Food and Drug Administration (FDA) to enforce the agency's regulatory ...
FDA proposes increased regulatory oversight of lab-developed tests
Because they're typically manufactured in smaller volumes, the FDA initially opted not to subject them to full regulatory review; the goal was ...
FDA finalizes lab developed test rule despite industry opposition
Under the new rule, most LDTs would be regulated as medical devices, subject to pre-market review as other in vitro diagnostics are now, which ...
Laboratory Developed Tests - FDA
Increased FDA Oversight to Help Ensure Safety and Effectiveness of LDTs ... Throughout this time, the FDA has maintained that patients and healthcare providers ...
FDA Brings Lab Tests Under Its Oversight - MedPage Today
Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning it has not enforced applicable requirements. LDTs ...
Laboratory Medical Tests: the FDA's Newest Regulatory Objective
On September 29, 2023, the Food and Drug Administration (FDA) released a proposed rule aimed at strengthening federal regulation of laboratory medical tests.
FDA Announces Final Regulation Governing Laboratory Developed ...
Currently, FDA regulates most of these tests using its enforcement discretion authority, and therefore the Agency has generally not enforced ...
FDA will begin to regulate thousands of lab tests - Medical Xpress
Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the ...
Clinical lab industry sues to block FDA's new oversight of lab ...
For decades, the FDA had allowed many lab-developed tests, or LDTs, to be used in patient care without prior review. They were originally deemed ...
FDA Wants to Oversee Lab Tests It Says Put Patients 'At Risk'
Genetic testing that reveals potential cancer risks or other maladies with no regulatory oversight is among the targets of the agency's proposed ...
FDA Moves Forward on Laboratory Developed Tests while ...
On April 29, 2024, after more than a decade of debate, Congressional activity, and proposed regulatory action, the Food and Drug Administration ...
FDA wants to regulate thousands of lab tests that have long skirted ...
Laboratory-developed tests have long skirted FDA oversight, though the agency has always maintained that it has the authority to step in. Debate ...
Clinical Lab Tests Need Stronger FDA Oversight to Improve Patient ...
In August 2020, the Department of Health and Human Services (HHS) announced that FDA does not have authority to require premarket review of LDTs ...