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  • Regulatory NewsRegulatory News

    Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance

    The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections. The website is part of an effort mandated by the 21st Century Cures Act to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive ...
  • Regulatory NewsRegulatory News

    Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

    As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans. The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results. A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Se...
  • 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...
  • Regulatory NewsRegulatory News

    Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results

    A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards. Following inspections last year, the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) each cited Theranos for a number of compliance issues. In a letter dated 30 June 2016, Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) call on Theranos CEO ...
  • Regulatory NewsRegulatory News

    Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

    The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates. FDA’s inspection found that Qiagen’s QuantiFERON-TB Gold (QFT) test device, first approved in 2005, “is adulterated … in that the methods used in or the facilities or controls used for, their manufacture, packing, storage, or installa...
  • 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 Calls Out Pathway Genomics for Marketing Unapproved Cancer Test

    Pathway Genomics is currently marketing an unapproved screening tool, which the US Food and Drug Administration (FDA) believes to be a medical device, for the early detection of up to 10 different cancer types, the agency said in a letter to the company this week. FDA says that the non-invasive blood test, known as CancerIntercept Detect, "appears to meet the definition of a device" as the company ships blood collection tubes, a medical device, for use with the tool. "W...
  • Regulatory NewsRegulatory News

    How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know

    The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
  • Regulatory NewsRegulatory News

    Australian Regulators Lift Ban on HIV Self-Test Kits

    Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...
  • Feature ArticlesFeature Articles

    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • US Regulators Approve First Over-the-counter HIV Test Kit

    Regulators at the US Food and Drug Administration (FDA) announced Tuesday, 3 July the approval of an over-the-counter (OTC) home testing kit for the detection of the Human Immunodeficiency Virus (HIV)-the first of its kind to be approved. The test, called the OraQuick In-Home HIV Test, is manufactured by Pennsylvania-based OraSure Technologies, Inc. OraQuick received overwhelming approval from FDA's Blood product Advisory Committee in May 2012, voting 17-0 to recomme...
  • OTC Test for HIV Approved by FDA Advisory Panel

    The US Food and Drug Administration's (FDA) Blood Products Advisory Committee voted 17-0 on 15 May to recommend OraSure's In-Home OraQuick HIV Test, the first such product to be approved for over-the-counter (OTC) testing for the Human Immunodeficiency Virus (HIV). According to clinical studies, the device is 99.98% effective at determining whether or not a person is infected with the HIV virus. The product had been faced with some early concerns about the accuracy of t...