- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.