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...

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...

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...

As decades of experience have shown, drugs can work very differently in different individuals. Advances in genetic sequencing and genomics made early in the last decade sparked the hope that identifying certain genetic characteristics or biomarkers would yield significant advances in healthcare and give rise to a new era of personalized medicine or, as it is often defined, the practice of administering "the right drug, at the right time, at the right dose, for the right p...

For years, the US Food and Drug Administration (FDA) has provided leeway to a sub-category of diagnostic tests known as laboratory-developed tests, or simply LDTs. But according to FDA Commissioner Margaret Hamburg, that era of enforcement discretion will soon come to an end. 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 expensiv...

Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed amendments to the new regulatory framework for in vitro diagnostic devices (IVDs) that covers both commercially manufactured IVDs and in-house IVDs (those IVDs developed or modified by providers for use in their own laboratories). Under the new regulatory framework, IVDs are deemed to be medical devices and, unless exempt, must fully comply with the new regulatory requirements as ...

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of its time and resources to investigating several programs run by the US Food and Drug Administration (FDA) during 2013. OIG's plans were revealed on 2 October in the release of its Fiscal Year 2013 Work Plan , a 123-page document detailing the basic outline of its investigati...

A report issued last week by the Institute of Medicine (IOM) calls on the US Food and Drug Administration (FDA) to become involved in the development of so-called "omics"-genomics, proteomics, metabolomics and epigenomics technologies-in order to provide guidance and better evaluate products used in clinical applications. The lack of "clearly defined development and evaluation processes has caused several problems," wrote IOM in a statement released 23 March. "The regula...