FDA
The new article addresses the aspects related to labeling for home-use medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
FDA
The article provides additional details regarding a 180-day supplement – a specific type of submission to be used in case of significant changes to the existing medical device. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The new article provides an overview of the human factors considerations related to home use of medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
FDA
The new article highlights the aspects related to a specific type of submission – a panel-track supplement. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article describes in detail the approach to be applied concerning certain specific aspects related to home use devices including, inter alia, the ones related to electrical issues, such as power outages or alarm systems. ...
FDA
The new article describes in detail the regulatory approach to be applied when determining the particular type of submission to be filed concerning the changes in question. Table of Contents The Food and Drug Administration (FDA or...
