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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.
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 355 - New drugs
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360i - Records and reports on devices
§ 360j - General provisions respecting control of devices intended for human use
§ 371 - Regulations and hearings
§ 374 - Inspection
§ 381 - Imports and exports
§ 393 - Food and Drug Administration
§ 264 - Regulations to control communicable diseases
§ 271 - Penalties for violation of quarantine laws
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 807 after this date.
The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through the Internet and would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device.
The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.
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 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) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In addition, this final rule would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.
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.