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  • Regulatory NewsRegulatory News

    Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

    The US Food and Drug Administration (FDA) updated its medical device safety action plan on Tuesday with “an important and ambitious new goal” and explained the path forward for its planned nationwide device surveillance system.   The new goal to propel the safety action plan— released in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA...
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    Senators Urge FDA to Clarify Intentions for Digital Health Pre-Cert Program

    With a proposed deadline of 9 November, three US senators sent a letter to the US Food and Drug Administration (FDA) on Wednesday to request more information on the agency’s pre-certification program for digital health.   FDA’s Center for Devices and Radiological Health (CDRH) recently adapted its regulatory processes to the rapidly evolving nature of digital health, while also encouraging questions like those from Sens. Patty Murray (D-WA), Elizabeth Warren (D-MA)...
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    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...
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    CDRH Works to Develop Proposed De Novo Regulation

    The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence. The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted...
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    CDRH Requests Labeling Changes on Certain Pen Needles

    In a letter to manufacturers of pen needles designed to be used with injectors, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) called for labeling updates to address the adverse events associated with improper patient use.   The request comes after the agency became aware of the reported incidents of hyperglycemia, diabetic ketoacidosis and at least one patient death through medical device reports and FDA’s adverse ev...
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    Special 510(k)s: FDA Seeks Input to Expand Eligibility

    Device manufacturers have two months to help inform US Food and Drug Administration (FDA) draft guidance on its Special 510(k) Program.   The 32-page draft guidance for industry and FDA staff is intended to update the policies set forth when the program was launched in 1998. At the time, modifications to the intended use of a device or any labeling changes were deemed inappropriate for special 510(k) submissions.   “We are proposing to evaluate whether design a...
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    What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

    While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence. The creation of this voluntary, alternative 510(k) pathway, first announced back in September , "will allow more flexibility to use more moder...
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    FDA Offers its Views on Medical Device Trials

    Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array of clinical trial designs and data sources that may be used to support the safety and effectiveness of medical devices. Unlike for pharmaceuticals, which generally see double-blind, randomized, Phase 3 trials assessing outcomes prior to approval, "practical limitations related ...
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    CDRH Seeks Participants for Staff Training Program

    Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices.  The training program, which is not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), is "is intended to provide CDRH ...
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    CDRH Lays Out Guidance Plans for FY 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017. The final guidance documents on the so-called “A-list” deal with some hot-button issues, including the use of real world evidence (which is also included on CDRH’s top 10 list of science priorities for 2017) to support medical device regulato...
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    CDRH Outlines Top 10 Science Priorities for 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for regulatory decisions, according to a list of its science priorities for 2017. As far as what will change between 2016 and 2017, the 13-page report says that thanks to more “needs submissions from staff,” CDRH was able to identify new topic areas, including clinical trial design and precision medicine, as well as desc...
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    FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced that it has completed its target goal under its 2014-2015 strategic priority on striking the right balance between premarket and postmarket data. The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data co...