Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry; Availability
other · Food and Drug Administration · Rule · Published 2022-03-23 · 87 FR 16391
Document
Document number
2022-05776
Federal Register citation
87 FR 16391
CFR reference
21 CFR 4
Type
Rule
Action
Notification of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2022-03-23
HHS docket
Docket No. FDA-2022-D-0192
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR part 4." This guidance describes FDA's compliance policy with respect to the requirements of FDA regulations that are now applicable to ophthalmic drugs that are packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic use.