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    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
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    FDA Declares ‘General Wellness’ Devices Exempt From Regulations

    The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements. Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons." As in the...
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    Medical Device Companies to See Slight Discount in FDA User Fees in 2017

    Medical device companies will see a modest decrease in application fees for FY 2017 when compared to 2016, according to new fee rates released Thursday by the US Food and Drug Administration (FDA). The 2017 standard fee for a premarket application, premarket report and efficacy supplement (in effect from 1 October 2016 to 30 September 2017) will be $234,495, which is $26,893 less than FY 2016’s fees . Panel-track supplement fees, however, will reach their lowe...
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    European Regulatory Roundup: Sandoz, Sanofi and Teva Drugs Face Suspension After EMA Faults Bioequivalence Tests (28 July 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Sandoz, Sanofi and Teva Drugs Face Suspension After EMA Faults Bioequivalence Tests The European Medicines Agency (EMA) has recommended the suspension of drugs from Sandoz, Sanofi, Teva and other companies following an investigation into a bioequivalence testing site. EMA found the testing company, India’s Semler Research Centre, had substituted and manipulated clinical samp...
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    FDA Finalizes Guidance on Adaptive Designs for Device Studies

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity. FDA says it received 151 comments from seven entities , including the Advanced Medical Technology Association (AdvaMed) and AstraZeneca, on the draft guidance and “incorporated most of them in this final guidance.” Guidance Adaptive trial designs , first...
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    FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. The 21-page draft document, which is open for comment for the next 90 days, also explains how the agency plans to evaluate real-world data to determine whether it may be sufficiently relevant a...
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    UDI Form and Content: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule. Background A UDI is composed of (1) a device identifier (DI), (2) typically one or more production identifiers (PIs) when included on the device label, and (3) the data del...
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    European Commission Pushes for Closer Convergence With US on Device Regulations

    As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations. The text of the proposal discusses some of the high-level themes of what both sides would to like find more common ground on, including the convergence of technical and clinical requirements applicable to devices; removing...
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    FDA Commissioner Calls for Better National System to Track Device Safety

    The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA . The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outco...
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    UK’s MHRA Introduces Re-Manufacturing of Single-Use Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that single-use medical devices may be re-manufactured for use in the UK, though the remanufacturers should meet all relevant criteria under the appropriate device directives and place a CE mark on their product. The shift to allow such re-manufacturing comes with new guidance from MHRA, which notes that the re-manufacturing of single-use devices and similar processes have existed outsid...
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    FDA Warns Medtronic Subsidiary Over Adulterated Devices

    Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx. The letter, dated 2 June, follows an inspection of the company’s Monmouth Junction, NJ-based site from 30 November 2015 through 12 February 2016, with respect to Tyrx’s Antibacterial Envelope, Antibacterial Absorbable Envelope, which is intended to reduce the cha...
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    FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices

    A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing clinical data to support pediatric medical device indications and labeling. The guidance, which, like the draft from May 2015 , reveals FDA’s concerns with the paucity of scientific evidence substantiating medical device submissions for pediatric indications, outlines ways in whic...