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  • Regulatory NewsRegulatory News

    Fourth notified body designated under IVDR

    Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR).   TÜV SÜD, Germany’s second notified body under the IVDR, joins Germany’s DEKRA Certification GmbH and BSI’s UK and Netherlands arms, BSI Assurance UK Ltd and BSI Group The Netherlands B.V.   The newly designated notified body will be a welcome addition for industry, as the number of notified bodies des...
  • Regulatory NewsRegulatory News

    FDA Proposes Radiological Health Deregulatory Action

    The US Food and Drug Administration (FDA) on Friday proposed to amend and repeal parts of the current radiological health regulations regarding certain recommendations, including radiation protection during medical procedures and performance standards for diagnostic x-ray systems. The action sought via the new proposed rule also covers recommendations under the radiological health regulations on diagnostic x-ray systems’ major components, laser products, ultrasonic ther...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Oncology Companion Diagnostics

    The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling. “We’re concerned that the situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, obtain an additional biopsy from a patient or both, to have additional therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott G...
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    FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation

    After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May , the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes. At the outset of the investigation, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the agency was working to determine the root ca...
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    New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs

    In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to submit a new 510(k) for certain changes to their tests. Under the policy laid out in the 2003 guidance , IVD makers can add either a cleared reagent to a previously cleared instrument or a new instrument "family member" to a previously instrument family without requiring a new 510(k). FDA...
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    FDA Warns Lead-Testing Diagnostics Company

    The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations. The warning letter, which follows an inspection of the North Billerica, MA, site last May and June, notes that Magellan made a "significant change by adding to the device labeling an ins...
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    EMA Lays out Plans for Companion Diagnostic Guideline

    The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines. Specifically, EMA says its guideline will address the development of companion diagnostics for precision medicines in the clinical development and post-approval phases, and will include a glossary defining terms used in the guideline as...
  • Regulatory NewsRegulatory News

    FDA: Lead Test Company May Have Violated Federal Law

    The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems. FDA cited the issues in a 10-page inspection report stemming from a month-and-a-half long inspection of Magellan's North Billerica, MA facility from 10 May to 29 June 2017. A week into that inspection, FDA warned the public that all four of Magel...
  • Regulatory NewsRegulatory News

    WHO to Craft Essential Diagnostics List

    The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL). The committee said the decision to begin developing such a list, agreed to earlier this month, may initially focus on in vitro diagnostics, with initial proposed priority areas including tuberculosis, malaria, HIV and hepatitis B and C. According to WHO , the list "should expand to other areas including other antimicrobial...
  • Regulatory NewsRegulatory News

    FDA Warns of False Results With Common Lead Test

    In the wake of a lead contamination crisis affecting cities across the country , the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances. According to FDA, all four of Magellan Diagnostics' LeadCare testing systems may provide inaccurate results when testing blood drawn from a patient's vein. However, the agency says it does not have reason to believe the ...
  • Regulatory NewsRegulatory News

    BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices

    Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...
  • 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...