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For me-too medical devices, on what basis should manufacturers choose biological tests to conduct?

Manufacturers producing a me-too medical device intended for implantation in the human body, conducting a full biocompatibility study including implantation effect that takes more than one year does not seem logical. With the availability of a reference medical device of the same material & intended use, how can the manufacturer choose the required biological tests?

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Charles Az
Demonstrating biologicaal equivalence with the current known products in key tests will be a good place to start. 
Type
Public
Status
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Bounty
1 Ping Credit
Created
04/22/2023
Answer Count
1
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Creator
Medhat Al-Ghobashy
Tags
Analytical toxicology Clinical and translational toxicology Medical devices Molecular and biochemical toxicology Regulatory and Safety Evaluation Risk assessment