FDA Watch

Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs

On August 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which take effect on … [Read more...]


White House requires all private-sector employers with 100 or more employees to mandate vaccination or a weekly negative COVID-19 test

By Mike O'Brien President Biden spoke from the White House Sept. 9 to announce his new Path Out of the Pandemic Plan. Among other things, President Biden has instructed the Occupational Safety and … [Read more...]


Model Lab Workplace Vaccine Passport Policy

Although courts have yet to weigh in on the issue, guidelines from the US Equal Employment Opportunity Commission and other regulatory agencies indicate that employers may implement vaccine passports … [Read more...]

Inside the Lab Industry

Resurgence of COVID-19 Cases Threatens to Derail Recovery of Core Business

Back on July 1, the perception was that the demand for COVID-19 testing was falling off faster than predicted. The silver lining to this cloud was the stronger than expected recovery of core … [Read more...]

Compliance Perspectives

The 5 Things to Do When Implementing a Vaccine Passport Policy at Your Lab

Like many labs and other health providers, you might have been undecided about whether to mandate that your employees get the COVID-19 vaccine. However, now that the FDA has fully approved a … [Read more...]


Paid leave for vaccine tax credit updated & employer ups premiums for unvaccinated

By Mike O’Brien Update to the paid-leave tax credit expansion—paid leave for employees to receive a COVID-19 vaccine  As previously described in these updates, the Treasury Department and the … [Read more...]

Compliance Alert

OSHA Orders Inspectors to Use the Hammer to Enforce New COVID-19 Protocols

On June 21, OSHA issued a new Emergency Temporary Standard (ETS) requiring labs, hospitals and other providers to take extensive measures to protect frontline workers against risk of COVID-19 … [Read more...]

DX Deals

Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry? Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Self-Disclosing Saves Kentucky Lab Over $1 Million in False Claims Settlement Case: A Kentucky-based lab that made heroic efforts to step up its COVID-19 testing early in the pandemic has agreed to … [Read more...]

Testing Trends

FDA Regulation of COVID-19 Testing Enters a New Phase

The public health emergency (PHE) is still in effect but the honeymoon has ended. The leniency that the U.S. Food and Drug Administration (FDA) has displayed toward COVID-19 tests and test makers … [Read more...]