The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
FDA is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. The Agency determined that an unreasonable and substantial risk of illness or injury may occur from using these medical products and...
Thor Rollins, consulting manager, and Audrey Turley, research scientist, have been invited to speak at the joint conference of the Association of Analytical Communities Southern California Section (AOAC SCS) and Food and Drug Agency (FDA) 2016 Spring Conference. Rollins and...
We may be seeing an increase in activity from medical device manufacturers as a result of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) which lifted the Medical Device Excise Tax for two years beginning January 1, 2016. Since January...
FDA announced new Office of Science and Engineering Laboratories (OSEL) Research Programs webpages. These webpages allow users to research by Clinical Area or by Special Topics. A few examples of searchable Clinical Areas are: Orthopedics, In Vitro Diagnostics (IVD), and...
Recently the US FDA issued a safety notice on Lubricious Coating Separation from Intravascular Medical Devices. The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough...
