United States
The article addresses specific aspects to be taken into consideration concerning premarket submissions for orthopedic devices with metallic or calcium phosphate coating, including the ones related to clinical testing, labeling, and modifications.
United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
United States
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
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.
FDA
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
