Source: http://www.law.cornell.edu/cfr/text/21/801/subpart-E?quicktabs_7=2
Timestamp: 2013-05-19 01:32:56
Document Index: 5927474

Matched Legal Cases: ['art 801', '§ 801', '§ 342', '§ 343', '§ 360', '§ 360', 'arts 660', 'art 801']

21 CFR 801, Subpart E - Other Exemptions | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
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21 CFR 801, Subpart E - Other Exemptions
§ 801.150 — Medical devices; processing, labeling, or repacking.
Title 21 published on 2012-04-01no entries appear in the Federal Register after this date. 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 CodeUSC : Title 21 - FOOD AND DRUGS§ 342 - Adulterated food§ 343 - Misbranded food§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use
Title 21 published on 2012-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 801 after this date.2013-04-19; vol. 78 # 76 - Friday, April 19, 201378 FR 23508 - Use of Certain Symbols in Labeling
typeregulations.gov FR Doc.2013-09175 RIN0910-AG74 Docket No.FDA-2013-N-0125 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit electronic or written comments on the proposed rule by June 18, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 20, 2013, (see section VII). See section IX for the proposed effective date of a final rule based on the proposed rule in this document. 21 CFR Parts 660, 801, and 809 SummaryThe Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a “standardized symbol”) and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement “Rx only” on the labeling of prescription devices.
2012-11-19; vol. 77 # 223 - Monday, November 19, 201277 FR 69393 - Unique Device Identification System
typeregulations.gov FR Doc.2012-28015 RIN0910-AG31 Docket No.FDA-2011-N-0090 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; amendment. Submit either electronic or written comments on the amendment to the Proposed Rule by December 19, 2012. See section VII for the proposed effective dates of a final rule based on the amended proposed rule. 21 CFR Part 801 SummaryThe Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule&apos;s requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.
2012-09-17; vol. 77 # 180 - Monday, September 17, 201277 FR 57055 - Agency Information Collection Activities; Proposed Collection; Unique Device Identification System; Extension of Comment Period