RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    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; ...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    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 ...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Feature ArticlesFeature Articles

    Impact of Clinical Utility Requirements on In Vitro Diagnostic Assays

    The term "clinical utility" has come into increasingly common usage as healthcare stakeholders direct greater attention to the determination and establishment of the value of healthcare services, interventions and technologies. The meaning differs somewhat among the various stakeholders depending on their roles and interests. For example, one Medicare contractor (Palmetto) describes its requirement for evidence of clinical utility as "demonstrates change in physician trea...
  • Newly-Approved Companion Diagnostic Promises Personalized Therapy for Lung Cancer Patients

    US regulators on Tuesday announced the approval of the US' first companion diagnostic test to detect a gene mutation associated with a type of lung cancer, giving lung cancer patients a similar diagnostic tool now available to patients with breast cancer. Background The product, approved 14 May 2013, is known as the Cobas EGFR Mutation Test, and acts as a companion diagnostic test to the already-approved cancer drug Tarceva. The drug's manufacturer, Astellas, wrote in a...