
Bookkeeping for Medical Device Reprocessors: When the FDA Calls You a Manufacturer
Third-party reprocessors of single-use medical devices are regulated as full manufacturers under the FDA's QMSR (effective February 2, 2026) — same 510(k), MDR, and UDI obligations as the OEM. That reshapes the books; a three-stage inventory split, per-device-family COGS, recurring validation expenses, and product liability reserves sized by risk class.










