Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more
Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health...more
As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. ...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19...more
In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more
The Food and Drug Administration (FDA) is working to expand the capacity to provide COVID-19 testing in the United States. In the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency...more