Apr 10, 2023
FDA
The document highlights the key points related to the regulatory requirements for certain orthopedic devices based on the draft guidance issued by the authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the...
Read More
Mar 30, 2023
FDA
The new article highlights the aspects related to the special framework allowing face masks intended for a medical purpose to be placed on the market under a simplified procedure. Table of Contents Introduction The Food and Drug Administration (FDA or the Agency), the...
Read More
Mar 30, 2023
FDA
The new article describes in detail the regulatory policy to be applied with respect to certain medical devices used in the context of the pandemic. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Read More
Mar 23, 2023
FDA
The article provides an overview of the regulatory approach to be applied with respect to certain medical devices used in the context of the pandemic. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Read More
Mar 23, 2023
FDA
The new article pays special attention to the situations when reports of assembly are not required and also provides additional recommendations regarding their content. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Read More