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    FDA authorizes new device to help diagnose pediatric autism

    The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years.   The device was developed by Cognoa, a company based in Palo Alto, CA, that develops diagnostic devices for the pediatric population. The company submitted its application, for the de novo pathway for new types of low-to-moderate-risk devices in September 2020.   ...
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    MDCG releases long-awaited IVD classification guidance

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR).   The nearly 50-page guidance is intended to explain how IVDs should be classified to manufacturers, notified bodies and healthcare providers before they are placed on the EU market and is seen as critical to industry’s ability to accurately classify ...
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    FDA Reclassifies Certain Device Accessories to Class I

    The US Food and Drug Administration (FDA) on Thursday published a final classification action that would reclassify eight types of medical device accessories to class I. The decision to reclassify the accessories — the final list is the same as the proposed list — is part of what’s required by the FDA Reauthorization Act of 2017 , which also reauthorized the user fee programs. The final classification action will be effective on 13 May, and the complete list of ac...
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    FDA Classifies IVDs for Bacillus Detection

    In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule. The IVDs are prescription devices and indicated to aid in the diagnosis of diseases caused by the Bacillus species, including anthrax. They are intended for the detection and differentiation of the bacteria, such as Bacillus anthracis , and had been unclassified devices prior ...
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    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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    CDRH Classifies Software App for Contraception into Class II

    Following the 2018 US Food and Drug Administration (FDA) approval of the country’s first mobile medical application indicated for contraceptive use, the agency issued a final order Tuesday to classify the software app for contraception as a class II device. The regulation set forth in the final order comes as a result of the 2017 de novo classification request FDA’s Center for Devices and Radiological Health (CDRH) granted  to Swedish startup company Natural Cycles Nor...
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    CDRH Seeks to Exempt Certain Flow Cytometers from 510(k) Reviews

    The US Food and Drug Administration (FDA) issued a proposed order Tuesday to exempt certain flow cytometer instruments from 510(k) requirements. The flow cytometer instruments are currently regulated by the agency as class II devices, which are subject to 510(k) reviews. But FDA’s Center for Devices and Radiological Health (CDRH) has determined premarket notification is no longer necessary to provide reasonable assurance of safety and effectiveness prior to market entry...
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    CDRH Classifies Auto Titration Device for Oral Appliances

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized on Tuesday the classification of the auto titration device for oral appliances into class II with special controls. The final order sets the new regulation on the dental device type based on the regulatory review of the 2017 de novo classification request CDRH granted to Zephyr Sleep Technologies’ MATRx plus, classifying the device into class II in August 2018. I...
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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 ...
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    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...