As per Guide to Inspections of Medical Device Manufacturers
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114981.htm,
routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device.
Under these conditions, could anyone advise when should be change the batch number to reflect that it is a reworked batch ?
Also I understand that in medical devices, there is no reprocess but only rework, right ?
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114981.htm,
routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device.
Under these conditions, could anyone advise when should be change the batch number to reflect that it is a reworked batch ?
Also I understand that in medical devices, there is no reprocess but only rework, right ?