|
|
|
|
|||
|
|
|
||||
|
|
820.65
Traceability.
Each manufacturer
of a device that is intended for surgical implant into the body or to support
or sustain life and whose failure to perform when properly used in accordance
with instructions for use provided in the labeling can be reasonably expected
to result in a significant injury to the user shall establish and maintain
procedures for identifying with a control number each unit, lot, or batch of
finished devices and where appropriate components. The procedures shall
facilitate corrective action. Such identification shall be documented in the
DHR. Interpretation:
Being able to effectively trace all your products is essential for facilitating correct action. Note that this is section of the regulation refers to surgical implants or to support or sustain life. This doesn't mean that you are off the hook for knowing where your products are. To find out more refer to QSR's 820.160 Distribution. However, this section indicates that the FDA wants the manufacturer to have a better handle on surgical implants or to support or sustain life.
|
|
|
||
|
|
|
||||
|
Reference: www.FDA.gov The informati on provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
|
||||
|
|
|
|
|
|
|
