Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment
other · Food and Drug Administration · Rule · Published 2016-08-11 · Effective 2016-08-11 · 81 FR 52994
Document
Document number
2016-18787
Federal Register citation
81 FR 52994
CFR reference
21 CFR 16
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-08-11
Effective date
2016-08-11
HHS docket
Docket No. FDA-2016-N-0011
Abstract
The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause.