Document issued December 3, 2025.
To comply with the GGP regulations ensuring that regulated entities and the public understand guidance documents as nonbinding, FDA guidance documents ordinarily contain standard language explaining the content to be viewed only as recommendations unless specific
regulatory or statutory requirements are cited.
FDA is not including this standard language in this guidance because it is not an accurate description of all of the effects of this guidance.
This guidance contains both binding and nonbinding provisions. Insofar as this guidance provides “standards,” “criteria for waivers,” and “exemptions” pursuant to section 745A(b) of the FD&C Act, it will have binding effect.
The eCopy Program does not intend to impact (reduce or increase) the type or amount of data that applicants include in submissions for clearance or approval. For the purposes of this guidance applicant includes “submitter”, “sponsor” or “holder.” Please refer to other FDA device or program-specific guidance documents from CDRH and CBER for the appropriate content to include in submissions.