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  • Regulatory NewsRegulatory News

    CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway

    Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...
  • Regulatory NewsRegulatory News

    FDA Plans to Finalize 510(k) Change Guidances Ahead of November Deadline

    An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act . In August 2016, FDA released the two draft guidances , five years after the agency's first attempt to replace its 1997 guidance on the topic. But, FDA withdrew the 2011 draft guidance after ...
  • Regulatory NewsRegulatory News

    FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. Established under the 21st Century Cures Act, the list, first published in draft form in March , is part of efforts to decrease regulatory burdens and costs for the device industry. For the complete f...
  • Regulatory NewsRegulatory News

    AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process

    Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer. In an amicus curiae brief filed with the nation's top court last week, AdvaMed takes issue with a decision from the US Court of Appeals for the Fourth Circuit, which upheld a $3.27 million j...
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    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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(...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...