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  • Regulatory NewsRegulatory News

    FDA Unveils List of Reusable Devices Requiring New Validation Data

    Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require validated instructions for use and validation data regarding cleaning, disinfection and sterilization in premarket notification submissions.  The list comes thanks to the 21st Century Cures Act (section 3059), which requires FDA to identify and publish a list of reusable...
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    Navigating the Medical Device User Fee Act (MDUFA)

    This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations. 1 Introduction The category "medical devices" encompasses a wide variety of products intended for diagnosing diseases or other conditions as well as the cure, mitigation, treatment or prevention of disease. 2 Among its responsibilities, the US Food and D...
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    When to Submit a 510(k) (Devices and Software): A Regulatory Perspective

    This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking. Introduction The design of a medical device often evolves over time. Design changes may be in response to changes in ...
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    Medical Device Performance Goals: FDA Offers a Quarterly Update

    The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015. On the approval side, FDA’s Center for Devices and Radiological Health (CDRH) continues to approve PMAs at a high rate and almost as quickly as the agency ever has. For 510(...
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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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    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...