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    Premarket Device Cybersecurity: Health Canada Issues Draft Guidance

     Health Canada posted a new draft guidance document on Friday to aid medical device manufacturers in complying with premarket cybersecurity requirements.   The move comes as more regulators seek to expand on considerations for the cybersecurity of medical devices as the health care sector became a prime target for cyberattacks amid an increasingly connected ecosystem.   The US Food and Drug Administration (FDA) issued premarket draft guidance for medical devices ...
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    FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations

    A US Food and Drug Administration (FDA) inspection at the McPherson, KS plant of Pfizer’s Hospira business revealed eight repeat FDA Form 483 citations dating back to 2012. FDA investigators conducted an inspection of the human sterile drug manufacturing site from late July to early August 2018, with the agency posting the Form 483 to its website Friday. The latest 483 comes after Hospira’s Kansas plant drew an FDA warning letter last year, with significant violations...
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    FDA Drafts Guidance on Oncology Companion Diagnostics

    The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling. “We’re concerned that the situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, obtain an additional biopsy from a patient or both, to have additional therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott G...
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    FDA Flags Lack of Design Controls at Mibo Medical Group

    A May inspection at a Mibo Medical Group manufacturing site in Texas revealed a lack of established procedures for controlling the design of its class II dry eye treatment device, distributed since 2014. The firm drew a US Food and Drug Administration (FDA) warning letter over nine significant violations of good manufacturing practices (GMP). The warning letter is largely focused on FDA’s observed failures around the firm’s lack of procedures to control the design of it...
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    Medtronic Fronts $51M to Resolve DOJ Case Over Unapproved Device Uses

    Medtronic agreed to pay $51 million in a case brought on by the US Department of Justice (DOJ) over introducing an adulterated medical device into interstate commerce. At the center of the off-label marketing litigation is the US Food and Drug Administration's (FDA) 2005 premarket approval on an use indication for a neurovascular device manufactured by ev3, which was acquired  by Covidien in 2010, which Medtronic acquired  in 2015.  ev3 launched a sales and marketi...
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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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    FDA Proposes Rule to Implement New De Novo Classification Process

    The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying new medical device types. If finalized, the rule will implement the de novo classification process and define the scope of regulatory procedures used by agency staff and classification panels convened by FDA when classifying and reclassifying medical devices. The work at FDA’s Center for Devices and Radiological Health (C...
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    Health Canada to Release Action Plan for Medical Devices Amid Reports of Faulty Implants

    Following a first-of-its-kind investigation into serious patient injuries associated with use of implants, the Canadian Minster of Health called on Health Canada to issue a new action plan for medical devices. “I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices,” said Minister of Health Ginette Petitpas Taylor. “Health Canada has been taking steps to strengthen its regulation of medical devices, and I ha...
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    Special 510(k)s: CDRH’s Proposed Program Expansion Draws Mixed Reactions

    Industry cautioned the special 510(k) program expansion proposal could yield the opposite of its intended goal and further limit eligibility of changes that undergo special 510(k) reviews. The main concern among several device companies, including Thermo Fisher Scientific, Cook Group and Fresenius Kabi USA, relates to a lack of clarity around the process used by agency staff to determine whether a submitted special 510(k) will be converted to a traditional 510(k) prior ...
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    WHO-FDA Pilot to Increase Patient Access to HIV Drugs in Resource-limited Countries

    The World Health Organization (WHO) forged a new partnership with the US Food and Drug Administration (FDA) to pilot an information sharing initiative for HIV drug applications. The plan was revealed Friday as part of the US government’s 15-year-old initiative known as the President’s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR bridges the gap between FDA and WHO’s prequalification unit for the purposes of approving or tentatively approving antiretroviral therapies....
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    Adaptive Trial Designs: BIO, Janssen, ACRO Call for Tweaks to FDA Draft Guidance

    Clinical research organizations along with pharmaceutical and biotechnology companies called for certain clarifications and terminology harmonization in the US Food and Drug Administration’s (FDA) recently released draft guidance on adaptive clinical trial designs. The Association of Clinical Research Organizations (ACRO), the Biotechnology Innovation Organization (BIO) and Janssen Research and Development, among others, submitted comments to FDA just ahead of the Fr...
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    FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

    The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test systems (BGMS) for point of care (POC) and over-the-counter (OTC) use and prepare 510(k) submissions for both device types. Both draft guidances propose changes to 2016 final guidances “based on feedback from stakeholders requesting more clarification on language,” FDA spokesperson Jennifer Rodriguez said...