The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more
The California Department of Public Health (CDPH) proposed changes to regulations regarding general acute care hospital (GACH) licensing requirements related to clinical laboratory, dietetic, and pharmaceutical services....more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year. ...more
At the start of the COVID-19 pandemic, each state and the federal government announced various states of public health emergencies which enabled them to suspend or modify various laws, rules, and regulations to accommodate...more
The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more
LEGISLATION, REGULATIONS & STANDARDS - California Passes Professional-Cosmetics, Animal-Testing Laws - California Governor Jerry Brown has signed a law that will bring labeling for professional cosmetics in line with...more