FDA Guidance on Discontinuance or Interruption Notification: Information
The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.
The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
The article highlights the key points related to the regulatory status of boundary products in Australia.