FDA Guidance on Notifying on Discontinuance or Interruption: Conditions
This article highlights the aspects related to the approach to be applied when determining whether a notification is required.
This article highlights the aspects related to the approach to be applied when determining whether a notification is required.
The article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the manufacturing process.
The article provides a general overview of the Risk Assessment and Software testing for Off-The-Shelf Sftware as given by FDA. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software...
The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a detailed guidance document dedicated to labeling requirements for various types of medical devices, including in vitro diagnostic...