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    FDA Kicks Off List of 503A Bulk Drug Substances List

    Six bulk drug substances added to the US Food and Drug Administration (FDA) list of substances can, for the first time, be legally used to compound drugs under a final rule issued by FDA on Friday. “Balancing patient needs for compounded products with patient safety is critical,” FDA Commissioner Scott Gottlieb said . “Patients still face too many risks when it comes to compounded drugs, which do not go through the premarket approval process.” Licensed pharmacists, ...
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    CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483. The draft standardized method has five parts. These relate to submitting a timely request—as defined by the agency—the statutory eligibility criteria, the device establishment’s ...
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    FDA Warns Doctor Over Unapproved Device

    In a 14-violation US Food and Drug Administration (FDA) warning letter, the agency flagged a doctor’s website for significant deviations from FDA quality system requirements and good manufacturing practices (GMP), as well as illegally marketing an unapproved device for a complication of breast implants. The warning letter was issued to Mark Berman of Beverly Hills, California for marketing the implantable Pocket Protector device online with claims and use indications ...
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    DITTA Pinpoints Cybersecurity Best Practices Amid IMDRF Work

    The industry group that set forth the new work item for a globally harmonized approach to medical device cybersecurity, which is currently under development, released a new white paper that provides an overview of best cybersecurity practices in medical technology manufacturing. The new white paper is intended to increase a manufacturer’s level of cybersecurity sophistication in manufacturing and engineering processes by following seven principles. These include segment...
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    Bipartisan Group of Lawmakers Urge Permanent Repeal of Device Tax

    A bipartisan team of eight Congressional leaders are circulating a “Dear Colleague” letter to urge fellow members of Congress to permanently repeal of the 2.3% medical device excise tax before it is reinstated next year. The device tax has only been in effect for two years—between 2013 and 2015—since it was introduced in 2010 under the Affordable Care Act . From device firms and industry groups to patient advocacy groups and health research organizations, the push agai...
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    E&C Leaders Seek FDA Briefing on Contaminated Sartans

    A bipartisan group of lawmakers who serve on the US House Committee on Energy and Commerce (E&C) sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday to request a briefing on the sartan safety issues that prompted a string of recalls worldwide. “Beginning in July 2018, there have been at least 15 recalls issued for a variety of angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure,” the E...
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    TGA Unveils Guidance on the Regulation of SaMD, Personalized Medical Devices

    Australia’s Therapeutic Good Administration (TGA) released further guidance Wednesday on the regulation of software, including software as a medical device (SaMD), and a separate new guidance to propose a regulatory framework for personalized devices, including 3D-printed devices. The 19-page SaMD document expands on guidance TGA posted last December. The 23-page proposed regulatory scheme for personalized medical devices comes after the agency launched a consultati...
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    Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

    A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews. The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marke...
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    Industry Lauds FDA RWE Framework, Calls for Tweaks

    The US Food and Drug Administration (FDA) regulatory framework for the use of real-world evidence (RWE) drew positive reactions from biopharma companies in comments submitted to the docket, although certain recommendations and proposals were also made. The agency released  the framework that describes its RWE program last December and has received 28 comments since then. The comment period remains open, but the submitted comments already offer a look into industry’s ta...
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    Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

    Australia’s Therapeutic Goods Administration (TGA) opened a consultation on Monday to obtain feedback on its proposal to reclassify all spinal implantable medical devices to a higher risk level. The consultation describes the reasoning behind changing the current Class IIb classification of medium-high risk on spinal implants to Class III under a new classification rule. It comes as part of an effort to align Australia’s regulatory requirements with the new framework of...
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    MHRA Clarifies Medical Devices Policies for Users

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a new guidance document on Monday to clarify existing policies and procedures around the use of medical devices. The agency’s guidance provides information that ranges from the definition of a medical device and CE marking to information on buying devices for personal use, as well as problems associated with device use and troubleshooting. For those interested in buying a medical device for pe...
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    HHS Floats Digital Health PreCert Approach as CDRH Limits Pilot Participation

    In a proposed rule from the US Department of Health and Human Services (HHS), the agency is seeking input on whether to expand on the US Food and Drug Administration’s (FDA) digital health pre-certification (PreCert) program for purposes of health IT certification. Yet FDA has said it will limit PreCert participation, for now. The 724-page proposed rule was unveiled on Monday by HHS’s Office of the National Coordinator for Health Information Technology (ONC). The move h...