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    FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices

    The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs). The Merlin@home device is used to communicate with a range of St. Jude's ICDs, including its radio frequency-ena...
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    FDA and MHRA Break Down Foreign Inspection Data

    Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics. On FDA’s side, investigators conduct on-site inspections of regulated foreign establishments to proactively ensure the safety and efficacy of products manufactured abroad and sold in the US. In FY 2016 , FDA conducted 78 foreign inspections of human dru...
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    Bipartisan House Bill Seeks to Repeal Medical Device Tax

    Rep. Erik Paulsen (R-MN) and a group of more than 220 bipartisan representatives on Tuesday introduced a bill that would permanently repeal the 2.3% tax on medical device companies under the Affordable Care Act (ACA). While the ACA is likely to be repealed and possibly replaced in full by the 115th Congress, this bill ( HR 184 ) would make permanent a delay that kept the tax from taking effect through next year. President-elect Donald Trump also has said he supports ...
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    FDA Finalizes Postmarket Cybersecurity Guidance

    Just before the close of 2016, the US Food and Drug Administration (FDA) finalized its guidance for managing postmarket cybersecurity for connected medical devices. While the core principles of the guidance are largely similar to the draft version released in January 2016 , FDA has made a number of changes to the guidance pertaining to cybersecurity vulnerability disclosure, remediating and reporting vulnerabilities, and participation in Information Sharing Analysis Org...
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    CDRH Speeds Release of Device Recall Information

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before. The information is now posted in CDRH’s Medical Device Recalls Database at the time a firm takes a correction (which addresses a problem with a device in the place where it is used or sold) or removal action (ie., Removing the device from the market...
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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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    FDA Bans Powdered Gloves

    The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017. FDA proposed the ban in March, citing mounting evidence that such gloves posed serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions. This is only the second time FDA has banned a medical device since banning prosthetic hair fibers in 1983. In April, FDA proposed banning a ...
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    NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage

    The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to the best new medical devices, diagnostics and other health-related technologies. FDA’s Center for Devices & Radiological Health (CDRH) initially established the PCTF to facilitate communication between device manufacturers and payers to pot...
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    FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices

    The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA). Under the guidance, FDA will issue more prompt notifications to the public about medical device "emerging signals," including information that supports a new causal association or a new aspect of a known association between a device and an adverse event, or new information determined by FDA to h...
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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(...
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    How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

    During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories. The 12-page guidance, first proposed in January 2015, notes that the risk of cross-conta...
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    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...