Banned Devices; General Provisions; Technical Amendment
other · Food and Drug Administration · Rule · Published 2015-06-02 · Effective 2015-06-02 · 80 FR 31299
Document
Document number
2015-13329
Federal Register citation
80 FR 31299
CFR reference
21 CFR 895
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-06-02
Effective date
2015-06-02
HHS docket
Docket No. FDA-2015-N-0011
Abstract
The Food and Drug Administration (FDA) is amending its regulations to clarify that the Agency will provide an opportunity for an informal hearing in connection with a proposed rule to ban a device with a special effective date. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).