21 CFR 814, Subpart B - Premarket Approval Application (PMA)

Title 21 published on 2012-04-01

no 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 Code

USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

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

USC : Title 21 - FOOD AND DRUGS

§ 360j - General provisions respecting control of devices intended for human use

§ 360i - Records and reports on devices

§ 360h - Notification and other remedies

§ 360g - Judicial review

§ 360f - Banned devices

21 USC § 360e–1 - Pediatric uses of devices

§ 360e - Premarket approval

§ 360d - Performance standards

§ 360c - Classification of devices intended for human use

§ 372 - Examinations and investigations

§ 373 - Records

§ 374a - Inspections relating to food allergens

§ 374 - Inspection

§ 375 - Publicity

§ 379 - Confidential information

Title 21 published on 2012-04-01

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

2013-02-25; vol. 78 # 37 - Monday, February 25, 2013

78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-04201
RIN	0910-AG48
Docket No.	FDA-2013-N-0080

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit either electronic or written comments on the proposed rule by May 28, 2013. See section VIII of this document for the proposed effective date of a final rule based on this proposed rule. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 27, 2013, (see the “Paperwork Reduction Act of 1995” section of this document).

21 CFR Parts 807, 812, and 814

Summary

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.

2013-02-19; vol. 78 # 33 - Tuesday, February 19, 2013

78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-03647
RIN	0910-AG29
Docket No.	FDA-2009-N-0458

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Supplemental notice of proposed rulemaking.

Submit either electronic or written comments on the proposed rule by April 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 21, 2013, (see the “Paperwork Reduction Act of 1995” section of this document).

21 CFR Part 814

Summary

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.

2012-09-17; vol. 77 # 180 - Monday, September 17, 2012

77 FR 57055 - Agency Information Collection Activities; Proposed Collection; Unique Device Identification System; Extension of Comment Period

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-22821
RIN	0910-AG31
Docket No.	FDA-2011-N-0090

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notification; extension of comment period.

Submit either electronic or written comments on the proposed collection of information by October 25, 2012.

21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

Summary

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.

2012-07-10; vol. 77 # 132 - Tuesday, July 10, 2012

77 FR 40736 - Unique Device Identification System

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-16621
RIN	0910-AG31
Docket No.	FDA-2011-N-0090

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule.

21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

Summary

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.

21 CFR 814, Subpart B - Premarket Approval Application (PMA)

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