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    EU IVDR compliance in a small organization

    This article presents a brief overview of the EU In Vitro Diagnostic Regulation (IVDR) requirements. It provides a user-friendly, step-by-step guide on how to comply with the regulation from first-hand experience and includes suggestions and tips for IVDR compliance through the lens of a small organization.   Understanding the changes of EU IVDR The IVDR, or Regulation 2017/746, 1 on in vitro diagnostics (IVDs) came into effect with its publication on 26 May 2017 ...
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    COVID-19 diagnostics: Moving from laboratory to home-based testing

    The US Food and Drug Administration (FDA) has worked closely with diagnostics developers during the past year to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled authorization of nearly one COVID-19 diagnostic per day, including at-home tests that have a critical role in the ongoing response to SARS-CoV-2. Introduction The emergence of the COVID-19 pandemic create...
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    FDA yanks EUA for serology test

    The US Food and Drug Administration (FDA) on Tuesday revoked the emergency use authorization (EUA) granted to Chembio Diagnostic Systems Inc. for its DPP COVID-19 IgM/IgG System based on several sets of data indicating that the test generates false results at a higher rate than expected. This is the first revocation of an EUA for a SARS-CoV-2 serology test during the COVID-19 public health emergency. The system in question is an antibody test for the novel coronavirus; ...
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    FDA Clears First Rapid Diagnostic Test for Ebola

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway. OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five mont...
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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 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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    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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    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...
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    FDA Finalizes Policy on Use, Approval of Companion Diagnostics

    The US Food and Drug Administration (FDA) has released a long-sought final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products—products intended to help guide the therapeutic use of new medicines based on a consumer's genetic characteristics. Background Regulators and industry have both been touting the benefits of companion diagnostics in recent years as the products have become, in the words of FDA, "more common." The benefits to both ...