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After going back to the drawing board numerous times over its guidance on personalized and 3D-printed medical devices, Australia’s TGA released more details on its proposed regulatory scheme. Read More
The European Commission has designated the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation. The NSAI is the first Irish notified body to be designated. Read More
The FDA is recommending changes to labeling for laparoscopic power morcellators (LPMs) used in gynecologic surgeries and says they should only be used in surgeries with a compatible containment system. Read More
India’s Ministry of Health and Family Welfare has established a transition timeline for its new medical device rules that go into force on April 1. Read More
The FDA issued draft guidances for devicemakers on using dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) waiver applications. Read More
A Kansas federal judge has certified two classes in an antitrust suit against Pfizer and Mylan over an alleged scheme to raise the price of EpiPen (epinephrine injection USP). Read More
FDA Commissioner Stephen Hahn said that the agency is not aware of any device shortages connected to the outbreak of the novel coronavirus, now known as COVID-19. Read More
The module on postmarket activities includes an overview of the quality system, exporting devices into the U.S., device recalls, inspections and global harmonization activities. Read More