The purpose of this document is to:
- inform readers of the Food and Drug Administration (FDA) regulations and policies relating to shelf life of medical devices.
- discuss the various parameters that determine the length of time a particular device will remain within acceptable specifications;
- outline the different activities that can be undertaken to establish the shelf life of a device.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.