Danielle Sloane on Food and Drug Administration (FDA)

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

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

5/7/2024 / Clinical Laboratory Testing , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry , Proposed Rules , Regulatory Oversight , Regulatory Requirements

FDA Takes Definitive Step Toward the Regulation of LDTs

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

10/4/2023 / Clinical Laboratories , Comment Period , Enforcement , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Proposed Rules , Regulatory Reform , Regulatory Requirements

Research Using De-Identified Specimens: A Reminder from FDA

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

10/25/2021 / Clinical Trials , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare , Investigational Device Exemptions , Investigations , IRB , Life Sciences , Medical Devices , Research and Development , The Common Rule

FDA Creates New Pathway for Authorization of COVID-19 Screening Tests

On March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more

3/26/2021 / Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Screening Procedures

Reimbursement and Liability Implications of Not Pursuing an Emergency Use Authorization for COVID-19 Laboratory-Developed Tests

In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more

9/3/2020 / CARES Act , Clinical Laboratories , Clinical Laboratory Testing , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Families First Coronavirus Response Act (FFCRA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Public Health Emergency , Uninsured Patients , Virus Testing

How the FDA's EUA for Convalescent Plasma Will Impact Healthcare Providers and Researchers

On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more

8/26/2020 / Clinical Laboratories , Convalescent Plasma , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Health Care Providers , Medical Research

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more

4/21/2020 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Testing , Public Health Emergency , Secretary of HHS

CMS Proposal Vastly Expands Medicare Coverage for Opioid Treatment

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took the first steps toward welcoming opioid treatment programs (OTPs) into the Medicare program and expanding Medicare coverage of opioid use disorder...more

8/14/2019 / Centers for Medicare & Medicaid Services (CMS) , Drug Treatment , Food and Drug Administration (FDA) , HCPCS , Medicare Part D , Opioid , Physician Fee Schedule , Prescription Drugs , Proposed Rules , Public Comment , SAMHSA

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

4/18/2019 / Clinical Laboratories , Direct to Consumer Sales , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Genetic Testing , Human Genes , Laboratory Developed Tests , Life Sciences , Marketing , Public Health

Danielle Sloane

Bass, Berry & Sims PLC

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