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    510(k) Submissions: CDRH Releases Four Final Guidances

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviated 510(k)s and CDRH’s refuse to accept policy for 510(k)s. As part of a wider, ongoing push to modernize FDA’s 510(k) program, the final guidance documents provide more clarity on several programs the agency has been working on...
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    CDRH Committee Discusses Challenges in Communicating Cybersecurity Concerns

    The US Food and Drug and Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday convened its Patient Engagement Advisory Committee (PEAC) to discuss the difficulties and challenges in communicating cybersecurity safety risks and threats. Since 2013, CDRH has released safety communication related to eight device cybersecurity concerns, although the center notes that issues are customarily disclosed when there is a software update to fix an is...
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    Help Wanted: CDRH Seeks Experts for 18 Advisory Panels

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday sought nominations for experts to serve as voting members of the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and panels that make up the Medical Devices Advisory Committee (MDAC). For DGMPAC, FDA is seeking experts in medical device quality management system requirements/current Good Manufacturing Practices, with experience in both 21 CFR part 820...
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    Survey From CDRH Officials Finds Informed Consent Process Needs Improving

    Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found. The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were...
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    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
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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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    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
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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 ...