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  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance on Organ Preservation Device Animal Studies

    As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices. Background The shortage of organs available for transplants has propelled a new wave of organ preservation technologies, FDA says, noting that these te...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    HHS Establishes Organ Donation Policy for Patients With HIV

    The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...
  • Bill Would Allow Donation of HIV-Positive Organs, Creating Parallel Donation Network

    Both the House of Representatives and Senate have now given their assent to a bill that would allow patients infected with the Human Immunodeficiency Virus (HIV) to donate organs to other HIV-positive individuals, a major reversal of longstanding policy that now awaits President Barack Obama's signature. Background Current tissue, cellular and organ donations policies in the US are geared toward the absolute minimization of risk with respect to the transmission of commu...
  • US HRSA Proposes Regulating Face, Hand Transplants

    The US Health Resources Services Administration (HRSA) wants to regulate face, hand, and other body part transplants much like it does for other organ transplants, according to the Washington Post . HRSA's proposal would also institute: waiting lists run by the United Network for Organ Sharing (UNOS); donor matching systems; organ distribution systems; and systems to test for diseases and infections. HRSA officials noted that they were seeking to issue the...