21 CFR 814 - PREMARKET APPROVAL OF MEDICAL DEVICES | LII / Legal Information Institute

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SUBPART A — General (§§ 814.1 - 814.19)
SUBPART B — Premarket Approval Application (PMA) (§§ 814.20 - 814.39)
SUBPART C — FDA Action on a PMA (§§ 814.40 - 814.47)
SUBPART D — Administrative Review [Reserved]
SUBPART E — Postapproval Requirements (§§ 814.80 - 814.84)
SUBPART F — G [Reserved]
SUBPART H — Humanitarian Use Devices (§§ 814.100 - 814.126)

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.

Source: 51 FR 26364, July 22, 1986, unless otherwise noted.

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

GPO FDSys XML | Text

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.

2011-06-01; vol. 76 # 105 - Wednesday, June 1, 2011

76 FR 31468 - Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-13488
RIN
Docket No.	FDA-2011-N-0318

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendments.

This rule is effective June 1, 2011.

21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814

Summary

The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

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 360e - Premarket approval

21 USC § 360e–1 - Pediatric uses of devices

21 USC 360f - Banned devices

21 USC 360g - Judicial review

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 372 - Examinations and investigations

21 USC 373 - Records

21 USC 374 - Inspection

21 USC 374a - Inspections relating to food allergens

21 USC 375 - Publicity

21 USC 379 - Confidential information

5 USC 552 - Public information; agency rules, opinions, orders, records, and proceedings

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 814

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

GPO FDSys XML | Text

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.

2011-06-01; vol. 76 # 105 - Wednesday, June 1, 2011

76 FR 31468 - Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-13488
RIN
Docket No.	FDA-2011-N-0318

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendments.

This rule is effective June 1, 2011.

21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814

Summary

The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

21 CFR 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

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