Keep Using Expired Forms Unless FDA Says Otherwise
[Thursday, March 7, 2019]

FDA uses several forms intended to be used for various regulatory applications. These regulatory forms are protected from alteration and need to accompany applications for appropriate processing. All FDA forms usually have a three year expiration which means every three years an updated version of a given form should be available to download from FDA’s website. However, it is not always the case. Several forms are available on FDA’s website beyond their stated expiration dates. However, these forms are still acceptable to FDA. As a general rule any form available for download from FDA’s website should be used even if it seems expired. And that is true for all other documents available on FDA’s website. Documents on FDA’s website not explicitly labeled as “Archival” material, should be used as current. For example, several FDA guidance documents stay in draft status or are very old but so long as they are available on FDA’s Guidance Documents page, they should be treated as current. At the same time, forms or documents that are no longer located on FDA’s website but may still be found at other locations on the internet should be considered obsolete. FDA uses its website as the primary way to communicate with the industry and public and constantly updates it. Hence it is very important that each time one needs a given form, one visits the FDA website to find and download it.