hirohama naoki
Registered
In tests related to safety, we require implementation under GLP (Good Laboratory Practice) conditions.
However, exploratory studies that determine physical and chemical properties are not considered non-clinical studies, and there are descriptions stating that GLP application is not required.
For bench performance tests of medical devices, confirmatory studies are recommended where criteria are predetermined and verification is conducted with statistical sample sizes.
However, to conduct confirmatory studies, it is necessary to predetermine the criteria, which sometimes requires preliminary studies (though it's uncertain whether these can be called exploratory studies).
Some companies use animals for verification in their preliminary studies.
For imaging devices, image quality tests related to noise are required as bench performance tests, but the level of noise that is clinically acceptable is determined through animal studies and doctor interviews.
The noise criteria established in this manner are adopted as bench performance test criteria and support 510(k) submissions.
My understanding is that such preliminary studies to determine criteria fall under exploratory studies and GLP is not mandatory. Is this understanding correct?
However, exploratory studies that determine physical and chemical properties are not considered non-clinical studies, and there are descriptions stating that GLP application is not required.
For bench performance tests of medical devices, confirmatory studies are recommended where criteria are predetermined and verification is conducted with statistical sample sizes.
However, to conduct confirmatory studies, it is necessary to predetermine the criteria, which sometimes requires preliminary studies (though it's uncertain whether these can be called exploratory studies).
Some companies use animals for verification in their preliminary studies.
For imaging devices, image quality tests related to noise are required as bench performance tests, but the level of noise that is clinically acceptable is determined through animal studies and doctor interviews.
The noise criteria established in this manner are adopted as bench performance test criteria and support 510(k) submissions.
My understanding is that such preliminary studies to determine criteria fall under exploratory studies and GLP is not mandatory. Is this understanding correct?
