• Regulatory NewsRegulatory News

    Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations

    The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). The 215-page discussion draft, known as the Diagnostic Accuracy and Innovation Act (DAIA), draws some similarities to another dr...
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    MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU

    The following article represents the views and interpretations of the author and do not necessarily reflect those of RAPS: This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR. Introduction Both the MDR: the EU Medical Device Regulation, 2012/0266 (COD) and ...
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    FDA Delays Finalization of Lab-Developed Test Draft Guidance

    The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated. Tara Goodin, press officer for FDA told Focus : "FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been...
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    FDA Clears First Zika Diagnostic for Emergency Use

    The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency. The authorization is significant as there are currently no other approved diagnostics available to detect Zika, a mosquito-borne virus that has rapidly spread across much of Latin America and the Caribbean and is thought to ...
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    WHO on Prequalified IVDs: Changes Must be Reported

    Manufacturers of prequalified in vitro diagnostics (IVD) must submit change reports to the World Health Organization or risk having their product de-listed from the compendium of prequalified IVDs. Reportable changes, according to new WHO draft guidance issued late last week, include: Changes to the IVD or how it’s manufactured that have the potential to impact an IVD’s function, performance, usability or safety Changes to a company’s quality management system (QMS), ...
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    House Committee Floats Draft Bill for New FDA Regulations of In Vitro Clinical Tests

    In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests. The 185-page draft bill lays out how it would create a new Center for In Vitro Clinical Tests within the US Food and Drug Administration (FDA). And although the bill refers to the tests as "in vitro clinical tests," it remains to be seen how FDA would regulate the tests differently from  in ...
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    FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications

    The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications. Background After scientific advances in the 1970s led to the first images produced using magnetic resonance (MR), clinical interest in the technology grew rapidly. In the 1980s, these advances made magnetic resonance imaging (MRI) useful for clin...
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    Types of In Vitro Diagnostics: Clearing Up the Confusion

    All in vitro diagnostics (IVDs) for human use are medical devices. After that, it is easy to get lost in a seemingly foreign language of acronyms—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? How does it even begin to know into which category its new device will fall? The US Food and Drug Administration (FDA) has several good guidance doc...
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    FDA Authorizes Sixth Device to Help in Fight Against Ebola

    The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act ( PAHPRA ) , a piece of legislation intended to bolster the government's ability to ...
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    FDA Provides Some Clarity to Complex Regulatory Environment for Molecular Diagnostics

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) aims to clarify the regulatory processes by which certain molecular diagnostic devices are approved or cleared by federal regulators. Background As FDA explains in its guidance document, Molecular Diagnostic Instruments With Combined Functions , molecular diagnostic instruments are "critical components of certain in vitro diagnostic device...
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    FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

    The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act  ( PAHPRA ), a piece of legislation intended to bolster the government's ability to respond to health ...
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    FDA Guidance Aims to Clarify Development of Medical Countermeasures

    A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical countermeasures. The guidance document, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices , is specifically aimed at those IVDs which are intended to simultaneously detect 20 or more pathogens extracted from a single sam...