FDA
The article highlights the aspects related to clinical images to be submitted by the applicant and also describes the approach to be applied concerning modifications to medical devices covered by the scope of the guidance.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
CDRH
This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential insights for manufacturers and healthcare professionals navigating the regulatory landscape Table of Contents In the...
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