|
 |
 |
Does an extension of product shelf life of a medical device require a Premarket Approval (PMA) supplement?
If FDA has previously reviewed and accepted a protocol for changes to the expiration date and testing was performed in accordance with that protocol, the change to the expiration date can be made and reported in an annual report. If not, a PMA supplement should be submitted.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
|
|
|
|
|
