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    Industry Groups Call for Clarity in New 510(k) Device Modifications Guidance

    Prominent medical device manufacturers and industry groups are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on submitting a new 510(k) for changes to a medical device. FDA released the draft guidance last August , five years after the agency's controversial first attempt to replace its existing guidance in 2011. However, FDA withdrew its 2011 draft guidance after Congress ordered the agency to rethink its p...
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    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
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    Common Pitfalls Associated with Modifications to 510(k)-Cleared and 510(k)-Exempt Devices

    This article identifies some common pitfalls companies often encounter when assessing modifications to 510(k)-cleared and 510(k)-exempt medical devices and offers approaches for performing these assessments to better ensure compliance with FDA expectations. Determining the regulatory impact of a modification to the design, labeling or manufacturing of a 510(k)-cleared or 510(k)-exempt medical device can be a challenging task for any regulatory affairs professional. The...
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    510(k) Third Party Review Program: FDA Offers New Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices. In an effort to encourage harmonization, the guidance refers to standards described in the International Medical Device Regulators Forum (IMDRF) documents as criteria FDA will con...
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    New Guidance Gives Device Makers More Leeway With 510(k)s for X-Rays

    The US Food and Drug Administration (FDA) has issued new guidance on submitting 510(k)s for x-rays, giving device makers more leeway on the information required to demonstrate substantial equivalence to an already approved product. The guidance, Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices , replaces the agency's 1999 guidance of the same name. In some cases, FDA says that "nonclinical information may be sufficient to support the substan...
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    FDA Issues Draft Guidance on 510(k) Device Modifications

    The US Food and Drug Administration (FDA) on Friday released two draft guidances for public comment clarifying its policy for when manufacturers should submit a 510(k) for changes made to a medical device or its software. According to FDA, the new guidances preserve "the basic format and content of the original, with updates to add clarity," which the agency says will help align industry and agency interpretations of when a device modification warrants further FDA review...
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    FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years

    A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies continue to seek more meetings with FDA on specific issues and targeted advice. As of 30 September 2015, the report says there are 57 programs participating in the biosimilar product development program (up from 33 in FY 2013 and 48 in FY 2014), and a total of seven Biologics L...
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    Fundamentals and Global Impact of 510(k) for Medical Devices

    This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers. Introduction The expansion of the global medical device healthcare market has been evolving rapidly in the 21st century Notably, clinical chemistry analyzers and in vitro diagnostics are estimated to reach $11.7 billion and $75.1 billion respectively by 2019 and 2020. 1, 2 Despite attractive opportunitie...
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    FDA Releases Draft Guidance on Displays Devices for Diagnostic Radiology

    The US Food and Drug Administration (FDA) released a new draft guidance intended to clarify the information device makers should include in their 510(k) submissions for displays used in diagnostic radiology. These devices are used to display, store, transfer or process medical images and are commonly used by radiologists to make diagnoses. Display devices are systems that use liquid crystal display (LCD) and light-emitting diode (LED) technology to display images in comb...
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    FDA Briefing Documents Offer Support for Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing. The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though th...
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    510(k) Submissions: Current Trends and Tips

    This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process. This past year has seen the 510(k) submission process evolve and the US Food and Drug Administration (FDA) take a more stringent stance on what submission materials will be accepted. To offset some of the technical impact of a stricter adherence to a more rigorous...
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    The 'Catch-Up' 510(k) - A Submission Often Overlooked

    This article discusses "catch-up" 510(k) submissions, circumstances under which a "catch-up" 510(k) submission should be considered, content and timing of such a submission and procedural recommendations for this submission type. Background The majority of medical devices are brought to market in the United States through the 510(k) pathway. A 510(k) clearance is based on FDA's review and concurrence with the submitter's substantial equivalence determination, allowin...