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    CDRH Draft Guidance Tackles Nitinol Devices

    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices. The draft guidance FDA’s Center for Devices and Radiological Health (CDRH) issued on Thursday covers the types of information to include in premarket submissions of devices made from nitinol, including material composition and manufacturing parameters, pseudoelasticit...
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    Sterilization Facility Closure Leads to First Device Shortage

    With the closure of a medical device sterilization facility in Illinois, the US Food and Drug Administration (FDA) warned of device shortages, and last Friday announced a type of a tracheostomy tube manufactured by Smiths Medical is the first to be in shortage. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement : “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization chal...
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    Exemptions for Unclassified Devices: CDRH Updates Guidance

    The US Food and Drug Administration (FDA) on Friday updated a guidance from 2015 describing its intent to exempt certain unclassified medical devices from premarket notification requirements. “Until the publication of a final rule exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period,” the guidance says. Un...
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    CDRH Revamps 510(k) Clearances With ‘Safety and Performance Based Pathway’

    A US Food and Drug Administration (FDA) final guidance sets the stage for how the agency intends to make the voluntary option for 510(k) clearance the main pathway for medical device regulatory reviews. The April 2018 draft version was finalized with a new title that is also the new name of the expanded alternative approach: “Safety and Performance Based Pathway.” The draft guidance proposed to expand the Abbreviated 510(k) program at FDA’s Center for Devices and Radi...
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    AdvaMed, MITA Call for Tweaks to CDRH’s Proposed FY 2019 Guidance Development Lists

    Industry groups offered feedback on the lists of guidance the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) proposed to develop during this fiscal year. The comment period on the guidance development lists proposed for medical devices closed earlier this week, with AdvaMed and the Medical Imaging & Technology Alliance (MITA) among those that responded to the October call   for feedback. The groups addressed the list of guida...
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    Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway

    Following Monday’s announcement from the US Food and Drug Administration (FDA) on its plans to remodel one of the review pathways for medical devices, industry trade associations pushed back on certain parts of the proposal that may hinder innovation. AdvaMed and the Medical Device Manufacturer Association (MDMA), among others, expressed mixed reactions to FDA’s policy proposals for modernization of the decades-old 510(k) framework. The device groups agreed with FDA ...
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    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...