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    Another Class I Recall of Ethicon Surgical Staplers, FDA Says

    Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples. Ethicon, a subsidiary of Johnson & Johnson (J&J), said that earlier this month it sent a letter to customers who purchased the affected...
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    Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA to Tighten Regulation of Autologous Cell Products, Ban Advertisements The Therapeutic Goods Administration (TGA) is planning to tighten oversight of autologous cell and tissue products. TGA’s proposed changes will bring some therapies under the biologicals regulatory framework, ban direct-to-consumer advertising and generally move Australia more in line with the ...
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    FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling

    The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Sharing Patient Info The five-page guidance, first released as a draft in June 2016 , is meant to convey FDA's position on manufacturers ...
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    Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

    Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine . The first look at the use of surgical mesh in New York between 2008 and 2011 found that use actually increased after FDA's first safety communication, from 21% of all procedures in 2008 to 30% in 2011. However, the use of surgical mesh later ...
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    FDA Increases Regulatory Requirements for Transvaginal Mesh

    The US Food and Drug Administration (FDA) announced Monday that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the devices. Various types of surgical meshes have been in use since the 1950s, and in 1992, FDA cleared the first transvaginal mesh to repair pelvic organ prolapse (POP) as an alternative to native-tissue repair. Under two final orders that take effect T...
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    Liquid-Proof Surgical Gowns? Now FDA Wants Companies to Prove It

    The US Food and Drug Administration (FDA) on Tuesday offered final guidance for companies that will have to conduct performance testing to support claims that their surgical gowns can keep out liquids and submit a 510(k) application within 60 days to the agency to prove those claims. Background In 2000, FDA issued a final rule clarifying the difference between gowns worn by health care personnel and surgical apparel worn by operating room personnel during procedures whe...
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    FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

    It is an iconic image replicated during almost every single infectious disease outbreak in the last century: men and women clad head to toe in surgical gowns and surgical masks, tending to the sick or working to disinfect contaminated areas. But iconic or not, the US Food and Drug Administration (FDA) has a more pressing concern: Are the gowns effective at protecting their users from the spread of infection? Background The question is the focus of a new draft guidance d...
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    Australia’s TGA Opens Review of All Surgical Mesh Devices

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for ma...
  • Snowstorm Costs Device Company a Million Dollars

    For most people, a snowstorm costs them time digging out their car or a sore back from shoveling. But for medical device manufacturer STAAR Surgical, a February 2014 snowstorm wound up costing it about one million dollars. How, you ask? The company was scheduled to meet with a US Food and Drug Administration (FDA) Advisory Committee on 14 February regarding a premarket approval (PMA) application for its Toric ICL intraocular implant. FDA's advisory committees provide th...
  • CGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive

    The US Food and Drug Administration's (FDA) Office of Criminal Investigations and the US Department of Justice (DOJ) have announced the indictment of William Zinnanti, the former President and Owner of Zinnanti Surgical Design, for selling devices to hospitals in violations of current Good Manufacturing Practices (cGMPs). According to a 15 May statement released by DOJ, Zinnanti Surgical Design manufactured a non-sterile surgical device used primarily in hospital setting...
  • FDA Orders Surgical Mesh Manufacturers to Study Risks

    The US Food and Drug Administration (FDA) issued a safety communication yesterday warning consumers about problems associated with surgical mesh implants and ordering manufacturers of the devices to conduct new studies in light of those safety concerns. The mesh, used to treat pelvic organ prolapse and stress urinary incontinence , has been associated with pain, infections, urinary problems, bleeding and discomfort .  FDA said that it has received more than 1,...