Hi all,

All our DMR documents are controlled and I was wondering which documents in the DHF should also be controlled.
Does anybody have a set of rules they use to determine if a document should be controlled or not?

thanks
Simon

Hi all,

All our DMR documents are controlled and I was wondering which documents in the DHF should also be controlled.
Does anybody have a set of rules they use to determine if a document should be controlled or not?

thanks
Simon

Hi Simon,

The FDA requirement for DHF http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1 is -

(j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

Thus all documents required to satisfy this criteria should be controlled.

Simon, another link - http://www.fda.gov/cdrh/qsr/03desgn.html#design_history_file