Document Revisions Required in DMR Index?

[Ajit Basrur]

by the way, i checked the regulation clause and its preamble and didn't find the requirement for DMR index. FDA just required the DMR shall be reviewed and approved up on review matrix according to documentation control and it shall be maintained and updated properly. Whether there is an index or not may be not critical to them.

The 21 CFR Part 820.181 Device master record clearly mentions "each DMR" in multiple places to indicate its uniqueness to the device.