Device History Record (DHR)

Under the FDA Quality System Regulation that applied before February 2, 2026, a device history record (DHR) documented that a manufacturer's batch, lot, or unit was produced in accordance with its specifications. The former 21 CFR 820.184 addressed manufacturing dates, quantities, acceptance records, labeling, and device identifiers. It did not define a DME supplier's patient assignment or cleaning log.

The FDA's Quality Management System Regulation (QMSR) took effect on February 2, 2026. It incorporates ISO 13485 and no longer uses the DHR term, although applicable device manufacturers must still maintain quality-system records. Renting a finished device does not by itself make a DME supplier subject to a manufacturer DHR requirement.

For day-to-day rentals, the relevant operational concept is unit history: which equipment went to which patient or customer, when it returned, and when staff changed its readiness status. Separate records may be needed for cleaning methods, inspection results, maintenance, proof of delivery, and recall response. A readiness timestamp does not prove that physical work occurred.

TrackDME shows recent recorded unit movements and rental assignments. It does not provide a manufacturer's full quality-system record or capture detailed cleaning methods, inspection results, maintenance logs, or proof of delivery. Keep those records in your existing process.