21 CFR 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

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Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.

Title 21 published on 2011-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2012-02-06; vol. 77 # 24 - Monday, February 6, 2012

77 FR 5696 - Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

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Additional Documents

type	regulations.gov
FR Doc.	2012-2558
RIN
Docket No.	FDA-2006-N-0364

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective February 6, 2012.

21 CFR Parts 201, 312, 314, 601, 610, 801, 807, 809, 812, and 814

Summary

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the interim final rule that issued regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). FDA is taking this action to complete the rulemaking initiated with the interim final rule.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

21 USC 360c - Classification of devices intended for human use

21 USC 360d - Performance standards

21 USC 360h - Notification and other remedies

21 USC 360i - Records and reports on devices

21 USC 360j - General provisions respecting control of devices intended for human use

21 USC 371 - Regulations and hearings

21 USC 372 - Examinations and investigations

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 809