The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.