24:05 is it 510K submission? I thought it is only class 1 devices that are only exempted from the design control requirements except for the class 1 devices listed under 21 CFR 820.30
I was talking about "IOR" which is the product code for a manual wheelchair. These devices are Class 1. Therefore, they are exempt from design controls. However, manual wheelchairs do require a 510(k). Therefore, a manual wheelchair is one of the odd examples of a 510(k) device that requires a 510(k), but you don't have to comply with design controls. However, you do need to do the verification testing for a manual wheelchair to make sure that they are safe. Inspectors that visit manual wheelchair facilities will not ask to sample a DHF for the manual wheelchairs, but they will verify that you have a device master record (DMR) and device history record (DHR) for your wheelchairs. The inspector does not need to review the testing reports, because they were already reviewed by the Office of Device Evaluations when the 510(k) was submitted.
I want to clarify I understand this. To be GMP exempt means that the device is exempt from quality system requirements except for what's in 820.180 and 820.198. Is that correct?
24:05 is it 510K submission? I thought it is only class 1 devices that are only exempted from the design control requirements except for the class 1 devices listed under 21 CFR 820.30
I was talking about "IOR" which is the product code for a manual wheelchair. These devices are Class 1. Therefore, they are exempt from design controls. However, manual wheelchairs do require a 510(k). Therefore, a manual wheelchair is one of the odd examples of a 510(k) device that requires a 510(k), but you don't have to comply with design controls. However, you do need to do the verification testing for a manual wheelchair to make sure that they are safe. Inspectors that visit manual wheelchair facilities will not ask to sample a DHF for the manual wheelchairs, but they will verify that you have a device master record (DMR) and device history record (DHR) for your wheelchairs. The inspector does not need to review the testing reports, because they were already reviewed by the Office of Device Evaluations when the 510(k) was submitted.
I want to clarify I understand this. To be GMP exempt means that the device is exempt from quality system requirements except for what's in 820.180 and 820.198. Is that correct?
You understand it perfectly!