The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more
Adult possession and use of cannabis has been legal in Maryland since Maryland’s Cannabis Reform Act (“CRA”) took effect in July 2023. The CRA established the Maryland Cannabis Administration (“MCA”) and tasked it with...more
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more
The California Department of Public Health (CDPH) proposed changes to regulations regarding general acute care hospital (GACH) licensing requirements related to clinical laboratory, dietetic, and pharmaceutical services....more
Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more
Model Overview - CMS as Negotiator - Under the model, CMS will negotiate OBAs with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with...more
The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as drafted) is intended to clarify the agency’s...more
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10...more
Hospital Executive and Three Physicians to Pay More Than $880,000 to Resolve Kickback Allegations - On Monday, December 4, 2023, a Lexington, Texas, hospital executive and three health care providers agreed to pay more...more
Cutting-edge technology is desirable to consumers for its ability to deliver innovative solutions, improved efficiency, enhanced user experiences, and the promise of staying ahead in an ever-evolving digital landscape. The...more
Before filing a lawsuit against FDA, I often get asked by clients whether FDA will retaliate by, for example, delaying review times or more closely scrutinizing applications. My response to this question is always the same –...more
The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion highlighting two important—if easy to overlook—areas that health care companies and providers should remain...more
Coming into the sixth month of work, Colorado’s regulated natural medicine program is starting to take shape. Answers to big-picture questions – such as what the scope of practice for a licensed facilitator is, and whether...more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more
In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
DOJ Enters Into DPAs with Former Deerfield Traders and CMS Consultant - On July 24, 2023, the US Department of Justice (DOJ) entered into deferred prosecution agreements with Theodore Huber and Robert Olan, former traders...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more