FDA
The article provides an in-depth review of the regulatory requirements for facet screw systems. Table of Contents The Food and Drug Administration (FDA or the Agency), has published a guidance document dedicated to the performance...
FDA
The new article describes in detail the core principles of the Safer Technologies Program introduced by the FDA to improve the regulatory framework for certain types of medical devices. Table of Contents The Food and Drug...
FDA
The new article addresses the aspects related to the manufacturing information the authority expects to be included in the submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The article provides an overview of the Safer Technologies Program, a special regulatory framework for medical devices introduced in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article describes in detail the content of the submission in terms of quality system information and also highlights the aspects related to the design control information. Table of Contents The Food and Drug Administration...
