Feb 26, 2024
United States
The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect necessary safety data to support the relevant claims included in the premarket submission.
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Feb 26, 2024
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.
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Feb 26, 2024
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.
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Feb 26, 2024
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.
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Feb 21, 2024
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.
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