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
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more
The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more
The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA warns...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more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
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests. On February 22, FDA issued a new Guidance for...more
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and...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
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody...more
Clinical laboratories across the country have ramped up their diagnostic testing capabilities to meet the critical need for COVID-19 testing, which is essential to mitigating the spread of the virus. Many labs are responding...more
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...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
On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use...more
The difficulties in accessing laboratory testing and securing prompt results present continuing challenges in the fight to control COVID-19. With scarce availability, there have been some attempts to limit tests to, or...more