Title 21 published on 2012-04-01
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.
The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
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.
§ 331 - Prohibited acts
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 355 - New drugs
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
21 USC § 360e–1 - Pediatric uses of devices
§ 360f - Banned devices
§ 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
§ 374 - Inspection
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 381 - Imports and exports
§ 382 - Exports of certain unapproved products
§ 383 - Office of International Relations
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 262 - Regulation of biological products
§ 263b - Certification of mammography facilities
42 USC § 259 to 261a - Repealed.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 812 after this date.
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.