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
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
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
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
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
IN THIS ISSUE Home medical tests and health monitors are trendy now. How useful are they? As the saying goes: Let the buyer beware - Shaking up hidebound medicine could be a plus. But will key safeguards also stay?...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
The U.S. Food and Drug Administration (FDA) has finalized their guidance related to medical devices that contain nitinol, the draft of which was published on April 19, 2019. The guidance recommends that companies clarify the...more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for 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 US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more