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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.
§ 552 - Public information; agency rules, opinions, orders, records, and proceedings
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
§ 360f - Banned devices
§ 360g - Judicial review
§ 360h - Notification and other remedies
§ 360i - Records and reports on devices
§ 360j - General provisions respecting control of devices intended for human use
§ 371 - Regulations and hearings
§ 372 - Examinations and investigations
§ 373 - Records
§ 374 - Inspection
§ 374a - Inspections relating to food allergens
§ 375 - Publicity
§ 379 - Confidential information
§ 381 - Imports and exports
Title 21 published on 20-Sep-2017 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 814 after this date.
The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.
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.
The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure.
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The Agency received significant adverse comment and withdrew the direct final rule. The Agency is issuing this supplemental notice of proposed rulemaking re-proposing the amendments reflecting comments received.
The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in the Federal Register of July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
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.