Uncategorized International Medical Device Regulators Forum, a voluntary group of medical device regulators, emphasizes the importance of the terminology issue and submits a proposal to amend the existing system. Focus on Terminology IMDRF proposes to add a special annex...
FDA The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
Australia and Oceania The Therapeutic Goods Administration (TGA) of Australia has published a notice describing the approach to delays in medical device conformity assessment recertification. The document is intended to address the issues related to the outbreak of COVID-19 caused by the...
FDA The Food and Drug Administration (FDA) has published draft guidance on updates for biocompatibility of certain devices in contact with intact skin. Notes The public consultations period commenced on October 15, 2020, and would last for 60 days during which the...
MHRA The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published the Target product profile (TPP) for the tests intended for the point of care use to detect the virus SARS-CoV-2 (the “novel...
FDA The Food and Drug Administration (FDA) has published an enforcement policy for modifications to FDA-cleared molecular influenza and RSV tests in the context of the outbreak of the COVID-19, and the public health emergency associated thereto. Important notes Due to the...
