fda-device · Food and Drug Administration · Rule · Published 2022-03-29 · Effective 2022-03-29 · 87 FR 17949
Document
Document number
2022-06508
Federal Register citation
87 FR 17949
CFR reference
21 CFR 822
Type
Rule
Action
Final rule; technical amendments.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-03-29
Effective date
2022-03-29
HHS docket
Docket No. FDA-2021-N-0246
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations, and to remove a submission requirement that is no longer necessary.