Device Master Records - Record Retention

The QS regulation in requires that all records pertaining to a device shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer.

Manufacturers of long life products should make prudent decisions as to how long to keep records. For example, there may be no value in keeping records for long¬ life devices such as stretchers, surgical tools, containers, etc., forever if the probability is low that any post¬ distribution remedial activity will occur.

For devices that require repair or capital equipment devices that probably will be updated, appropriate records should be retained to support these repairs or modifications.

Device master record requirements apply to devices modified in the field by the manufacturer's representatives after the devices are commercially distributed.

Modification of a device is manufacturing and the QS regulation covers all manufacturing of devices where the result is placed into commercial distribution. In any case, a manufacturer should be prepared to provide a rationale for its decision to discontinue record-keeping.