FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
FDA
The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party review program under the 510(k) framework.
United States
The article provides a brief overview of the existing legal framework associated with the third-party review.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
FDA
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.
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