FDA Guidance on Electronic Submissions for 510(k): Current Template
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
The new article highlights the aspects related to non-clinical testing considerations related to the devices covered by the scope of the guidance.
This article highlights 21 CFR part 11, its scope, applicability and effective ways to maintain regulatory compliance. Table of Contents 21 CFR Part 11 is a regulation introduced by the United States Food and Drug Administration (FDA) that sets forth the criteria...