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GUIDANCE DOCUMENT

Shelf Life of Medical Devices April 1991

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

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