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  • Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on 510(k) Device Modifications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...
  • Feature ArticlesFeature Articles

    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    FDA Releases Draft Guidance on Displays Devices for Diagnostic Radiology

    The US Food and Drug Administration (FDA) released a new draft guidance intended to clarify the information device makers should include in their 510(k) submissions for displays used in diagnostic radiology.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...
  • Feature ArticlesFeature Articles

    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...
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    Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections

    As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications. The shift in FDA’s thinking comes as the agency says in Wednesday’s final guidance, issued more than seven years after the draft document was released, that it’s received “an increasing number of 510(...
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    FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say

    The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...
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    FDA Sees Record-High PMA Approval Rate for 2015

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005, according to a 371-page quarterl...
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    Senators Introduce Two Bills to Streamline FDA Reviews of Medical Devices

    Sens. Cory Gardner (R-CO) and Joe Donnelly (D-IN) late Wednesday announced the introduction of two new bills that would further streamline the US Food and Drug Administration (FDA) approval process for certain medical devices. One of the bills -- the Rare Device Innovation Act -- would expand the threshold by which FDA could approve medical devices that treat rare diseases, including ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma and tuberculosis. Currently, FDA...
  • Regulatory NewsRegulatory News

    FDA Workload, Spending on Biosimilars Program Picks Up in 2015, Report Says

    In the first two and a half years of the US Food and Drug Administration (FDA)’s biosimilars review program, the agency is only recently starting to ramp up spending and manpower, according to an interim report from Eastern Research Group (ERG) released Wednesday. Background Under the Biosimilar User Fee Act (BsUFA), enacted by Congress in 2012, FDA was required to contract with an independent consulting firm to develop an estimate of the workload volume and full costs ...