The US Food and Drug Administration (FDA) has finalized its guidance to establishments that screen human tissue and cell donors for various communicable diseases on screening for Treponema pallidum , commonly known as syphilis. Background Under 21 CFR 1271.80 , establishments that screen donors of human cells, tissues and cellular and tissue-based products (HCT/P establishments) are required to screen for specific diseases, such as syphilis, human immunodeficiency vi...

The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies. Background The move is related to FDA's efforts late last year to regulate LDTs more similarly to traditional medical devices, and in particular in vitro diagnostics (IVDS). FDA has long maintained its authority to regulate LDTs, which are tests devel...

Regulators in the UK are asking the public to report “suspected adverse effects” of hormonal pregnancy tests (HPTs), which have been off the market in the UK since the late 1970s after being associated with serious birth defects and miscarriages. The information will be used as part of an independent review to determine whether there is a causal relationship between HPT use and reported side effects. MHRA is asking for submissions by 30 June 2015, and says the repo...

A new legal whitepaper authored by two of America's most prominent lawyers argues that the US Food and Drug Administration's (FDA) plan to regulate lab developed tests (LDTs) more similarly to traditional medical devices lacks legal justification and is therefore unlawful. For more on LDTs and why and how FDA wants to regulate them, please see our August 2014 explanation of the policy shift here. The legal analysis is co-authored by  Paul Clement, the former US ...

US regulators have released new recommendations for manufacturers of psychoactive drugs—including sleep aids—following several warnings by the US Food and Drug Administration (FDA) that some drugs were causing patients to get into car accidents hours after the effects of the drug should have worn off. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond atypically,...

A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...

The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...

Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups , including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress. Background LDTs are, as their name imp...

In recent weeks the US Food and Drug Administration (FDA) has undertaken major steps meant to bring lab-developed tests (LDTs)—devices developed, tested and used within a single laboratory—under stricter regulatory controls. But now new questions are being raised about whether the agency is using the correct methods to enact those changes. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval thro...

Muscular dystrophy (MD)––a group of diseases that cause progressive muscle weakness due to defects in muscle proteins ––has a range of complex features that make treatments elusive. MD exists in many forms (Duchenne MD is the most common); animal models do not accurately reflect human disease; and it is difficult to define and measure the progression of this slow disease. Because MD can be life-threatening, new disease-modifying (serving to slow or halt progression) an...

The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs). Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a...

The US Food and Drug Administration (FDA) may be the federal government's regulator of most medical products, but at least one federal agency is looking to conduct basic reviews of the safety and efficacy of one type of medical product FDA says it has the authority to regulate. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and e...