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  • Regulatory NewsRegulatory News

    TGA Proposes 5 Medical Device Classifications in Line With EU MDR

    In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).  The consultations consider the current classification requirements in Australia for five specific medical device types and either propose new classification rules to be incorporated into the existing Australian medical device regulations or classification changes. Propo...
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    FDA Proposes Rule to Implement New De Novo Classification Process

    The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying new medical device types. If finalized, the rule will implement the de novo classification process and define the scope of regulatory procedures used by agency staff and classification panels convened by FDA when classifying and reclassifying medical devices. The work at FDA’s Center for Devices and Radiological Health (C...
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    CDRH Finalizes Classifications on Anesthesiology, ENT Medical Devices

    The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued two final orders Thursday, classifying an anesthesiology and an ENT device into class II.   The classifications complete the work on the de novo classification requests submitted to CDRH in early 2017. Vapotherm’s de novo request for the classification of the Precision Flow HVNI, which is designed to help patients breathe easily, was granted in April. The de novo request for ...
  • Regulatory NewsRegulatory News

    CDRH Issues Final Orders on 6 Medical Device Classifications

    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.   The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH rece...
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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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    FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced that it has completed its target goal under its 2014-2015 strategic priority on striking the right balance between premarket and postmarket data. The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data co...
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    FDA Identifies More Than 20 PMA Devices Eligible for Reclassification to Class II

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes. Balancing pre- and post-market data collection is one of the FDA...
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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 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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    Final Rule Seeks More Stringent Regulation of Tanning Lamps

    The US Food and Drug Administration (FDA) has issued a final rule which will regulate ultraviolet lamps used for tanning more stringently, reflecting the lamps' association with skyrocketing rates of skin cancer. Background At present, sunlamp products—commonly used in tanning beds—are Class I medical devices that are exempt from premarket review procedures. The devices have been marketed since before the 1976  Medical Device Amendments , which effectively regulated me...
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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...
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    FDA Down-Classifies Colon, Intravascular Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation. In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devi...