Nov 16, 2023
FDA
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
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Nov 16, 2023
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
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Nov 15, 2023
FDA
The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.
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Nov 15, 2023
FDA
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.
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Nov 2, 2023
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
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