21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES | US Law

prev | next

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 2015-04-01.

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.

2015-04-03; vol. 80 # 64 - Friday, April 3, 2015

80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment

GPO FDSys: XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2015-07268
RIN
Docket No.	FDA-2015-N-0011

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule; technical amendment.

This rule is effective April 3, 2015.

21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271

Summary

The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure 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

U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

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

U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

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