21 CFR 801.5 - Medical devices; adequate directions for use.

§ 801.5

Medical devices; adequate directions for use.

Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of:

(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.

(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.

(d) Duration of administration or application.

(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.

(f) Route or method of administration or application.

(g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process.

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 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 2012-04-01

The 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, 2013

78 FR 23508 - Use of Certain Symbols in Labeling

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-09175
RIN	0910-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

Summary

The 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, 2012

77 FR 69393 - Unique Device Identification System

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-28015
RIN	0910-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

Summary

The 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'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, 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 801.5 - Medical devices; adequate directions for use.

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