The article provides an overview of the regulatory policy related to the Abbreviated 510(k) Program and highlights the key points associated thereto.  ...

The article provides an overview of the regulatory policy for pivotal clinical investigations in terms of design considerations.  Table of Contents ...

The new article describes in detail the aspects related to establishing the appropriate record for the assurance of the software used in the course...

The new article highlights the aspects related to the way the risk related to general wellness products should be determined.  Table...

The article provides an overview of the existing regulatory requirements related to the abridged processing of applications for medical devices. Table...

The new article describes in detail the way the appropriate assurance activities should be determined.  Table of Contents The Food and...

The article provides an overview of the regulatory policy for low-risk medical devices.  Table of Contents The Food and Drug Administration...

The new article describes in detail the aspects related to a risk-based approach and the way it should be applied concerning computer software assurance...

The new article describes in detail the aspects related to timing for regulatory procedures in the context of the least burdensome approach.  ...

The new article describes in detail the process of determining whether computer software used in the context of medical device manufacturing processes should be...

The new article describes in detail the aspects related to smart regulation and global harmonization for all the procedures and processes related to placing...

The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests,...