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    CDRH Finalizes Classifications on Herpes Virus IVD, Limb Tremor Stimulator

    In final orders issued Tuesday, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) classified two new device types into class II (special controls).   The two devices are named “herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel” and “external upper limb tremor stimulator.”   Both of the new de novo classifications are intended to “enhance patients’ access to beneficial innovative devices, in part by reduci...
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    Not Just Mylan: Misclassifications May Have Cost Medicaid More Than $1B

    The US Department of Health and Human Services' (HHS) Office of Inspector General (OIG) released a report this week finding that drugmakers may have caused the Medicaid program to lose out on $1.3 billion for 10 potentially misclassified drugs from 2012 to 2016. The release of the report follows a settlement between Mylan and the Department of Justice from August in which the drugmaker agreed to pay $465 million to settle claims relating to the misclassification ...
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    FDA Finalizes Combination Product Classification Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices. The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act , and details how F...
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    International Generic Drug Regulators Unveil New Biowaiver Assessment Template

    Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members. IGDRP, which is made up of regulators from all over the world including the US Food and Drug Administration, Health Canada, European Medicines Agency and China Food and Drug Administration, among others, created its Bioequivalence Working G...
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    ICH Proposes Two New Guidelines

    The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while the other (M10) applies to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. Both of the new plans for the guidelines are part of efforts to harmonize regional differences in guidance documents and were finalized by ICH ...
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    New Senate Bill Would Change the Way FDA Regulates Devices

    A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices. The bill, which is sponsored by Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS), and supported by industry group AdvaMed, would also: Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internati...
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    Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015

    The number of medical device recalls appears to have plunged during the first quarter of 2015, a review of the US Food and Drug Administration's (FDA) data by Regulatory Focus has revealed. FDA has since last year been publishing data about its drug and device recall reports through its new open data platform, openFDA . The data make it much easier to assess trends in enforcement measures, including the number of recalls classified by FDA. A review of FDA's device r...
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    FDA Says it Will Regulate Robotic Exoskeletons

    The US Food and Drug Administration (FDA) has confirmed it will regulate all powered exoskeletons—a type of device intended to help paralyzed patients regain the ability to walk—as moderate-risk devices subject to a minimal level of premarket review. Background FDA's announcement comes as little surprise to close industry watchers. In December 2014, FDA notified exoskeleton manufacturer Ekso Bionics that its "Ekso" bionic suit would be subject to premarket controls. As...
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    Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System

    The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk. Background The proposed regulation is required under a 2012 law known as the  Food and Drug Administration Safety and Innovation Act (FDASIA) .  Section 608 of the law  called for FDA to be given the authority to make classificati...
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    FDA Classifies Cellulite-Reducing Device as Class II

    The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve "the appearance of cellulite" as Class II medical devices, making it easier for them to be brought to market. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices) Class II (moderate-risk devices) Class III...
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    FDA Moves Three Device Types into Class II Special Controls

    The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ensure their efficacy, safety and quality. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices), Class II (moderate risk) and Class III (high ...
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    FDA Proposes Strengthening Requirements for Rapid Flu Tests

    US Food and Drug Administration (FDA) regulators are proposing to reclassify some Influenza Antigen Detection Test Systems into a higher-risk category than the systems now inhabit, citing potential for the devices to fail to detect newer versions of the virus. Background The devices, which are used to detect the presence of influenza in a clinical sample, were Classified as low-risk Class I medical devices in 1982. Class I devices only require the company to adhere to g...