FDA Watch

Congress Retables VALID and VITAL Legislation to Regulate LDTs

The U.S. Food and Drug Administration’s response to the COVID-19 public health emergency has infused the longstanding efforts to overhaul the agency’s system of regulating Laboratory Developed Tests … [Read more...]


FDA Pulls the Plug on EUA Review of COVID-19 LDTs

Companies like Quest, LabCorp and others have been in the forefront of pandemic response by creating innovative new laboratory diagnostic tests (LDTs) for detecting the SARS-CoV-2 virus. The FDA has … [Read more...]

FDA Watch

Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. … [Read more...]


FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests

Bloated and unsubstantiated marketing claims about the capabilities of unproven serologic SARS-CoV-2 antibody tests have been a problem almost since the public health emergency began. After playing … [Read more...]

FDA Watch

Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

Industry Buzz

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]


FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform

April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the … [Read more...]


Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]


From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform

While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency's continued reliance on a regulatory regime designed not for lab tests but medical devices. … [Read more...]


Government Shutdown: The Impact on the Agencies that Regulate Labs

As we go to press, the longest U.S. government shutdown in history drags on with no end in sight. And while it may not affect your lab directly, the shutdown will have an indirect impact to the extent … [Read more...]