Product Stability Shelf-Life Procedure | ISO 13485 | FDA QMSR

The Shelf Life Procedure defines the required testing needed to support medical device shelf life claims. The Shelf Life Procedure provides instruction on product considerations, accelerated aging studies, and post accelerated aging product testing and reports.

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Shelf Life Procedure - Overview

The Shelf Life Procedure provides instruction on conducting accelerated aging and concurrent real time aging studies. The Shelf Life Procedure includes guidance on the preparation of product stability protocols and considerations, and the required content of a stability protocol.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.