FDA
The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
FDA
The new article describes in detail certain specific aspects related to the regulatory status of endosseous dental implants and performance criteria they should meet in order to be allowed for marketing and use in the US.
Medical Devices
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance. As connected devices become increasingly prevalent, cybersecurity has become a critical concern in regulatory submission.
FDA
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
FDA
The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.
FDA
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
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