• FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions

    The US Food and Drug Administration (FDA) is announcing the creation of a pilot program to expedite voluntary audit report submissions for medical devices. Under the pilot program, a device manufacturer may voluntarily submit an audit report to FDA so long as their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using: International Organization for Standardization (ISO) 13485...
  • TGA: PIP Implants in Australia not Likely to Rupture

    The Australian Therapeutic Goods Administration (TGA) today released statements indicating that, "there is no evidence of an increased rupture rate for PIP [Poly Implant Prothese] silicone gel breast implants used in Australia." TGA indicated that they have received 37 reports of PIP implant ruptures (.4%), which is in line with the expected rupture rate of all implants (1% per year). Approximately 8,900 Australian women have the implants. TGA had already recalle...