Скачать или смотреть QMS Tip - Do you have a procedure for release of product to a clinical study?

We have two procedures, and what you are asking for is a blend of the two:

1. SYS-008, Design Controls
2. SYS-009, Clinical Procedure

In most design projects, the verification and validation phase is phase 4. For most Class 1 and Class 2 device there is no requirement for a clinical study. Therefore, the validation is usually a simulation. However, in the case of a device that requires a clinical study, you should split phase 4 into two parts. Phase 4A = verification, and Phase 4B = validation. The reason for this is that verification testing usually needs to be completed before an IRB will approve your study protocol and before the FDA will approve an IDE if the study is higher risk (i.e., Significant Risk).

There is no "procedure" or "work instruction" to specifically approve the release of the product to be used in a clinical study. Instead, you approve the release of the device for a clinical study during a design review. That design review is conducted when the verification testing is completed. This would be documented in your design plan, and the design meeting minutes would be the record documenting approval to go ahead with the clinical study.

If the study is significant risk, then you need FDA approval first and then IRB approval. If the study is non-significant risk, then you only need IRB approval.