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Congress
Several Times, Feds Tried to ‘Redirect’ Lab Activities
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…
New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…
Congressional Subcommittee Hears Testimony on FDA LDT Rule
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
FDA Issues Memo to Reclassify Many High Risk IVD Assays
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
2024: Year of Decision for FDA Regulation of LDTs
By R. Lewis Dark | From the Volume XXX, Number 18 – December 26, 2023 Issue
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Year’s Top 10 Lab Stories Contain Surprises & Twists
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…
Congress Averts PAMA Cuts to Lab Test Rates for 2023
By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue
CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….
2022’s Top 10 Lab Stories Confirm Challenging Times
By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
Congress Votes: No PAMA Price Cuts for 2022
By R. Lewis Dark | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
IT’S WELCOME NEWS THAT CONGRESS VOTED EARLIER THIS MONTH to defer the PAMA price cuts to the Clinical Laboratory Fee Schedule (CLFS) that were scheduled to take place in 2022. This is a positive development for the finances of the nation’s clinical labs, particularly the smaller, independent labs t…
Congress May Soon Act on LDT, IVCT Regulation
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
CURRENT ISSUE
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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