Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122639.htm
Timestamp: 2013-12-09 01:24:43
Document Index: 642560317

Matched Legal Cases: ['art 801', 'art 809', 'art 812', 'art 820', 'art 1010', 'arts 1020']

11. Labeling Quick Links: Skip to main page content
Postmarket Requirements (Medical Devices)
Quality Systems Regulation
Medical Device Quality Systems Manual: A Small Entity Compliance Guide
11. Labeling
False or Misleading Labeling
Adequate Directions for Use
Sterile Devices
DESIGN OF LABELING
Write to the Reader
Refer to Actual Device
Obvious Identification of Controls
Don't Distract Reader
Introduce Each Item
Accentuate Key Terms
Select Words Wisely
Test Labeling
Label Integrity
Approval Policy and Procedure
Area Separation and Inspection
Label Check and Record
SHIPPING FOR PROCESSING
OVER­LABELING
Drafting and Approval of Labeling
Approval Form for Labeling, Advertising, Literature, etc.
Administration Set Label
Labeling Control Record
Device History Record: OB/GYN (Plate)
User/Reader Comments
Medical devices in commercial distribution in the U.S. shall be properly labeled according to laws and regulations enforced by the Food and Drug Administration (FDA). Specific labeling requirements for medical devices are contained in:
The Federal Food, Drug, and Cosmetic (FD&C) Act;
The Fair Packaging and Labeling Act;
The Radiation Control for Health and Safety Act;
Title 21 of the U.S. Code of Federal Regulations, Part 801 for general devices, and Part 809 for in vitro diagnostic products;
Title 21 of the U.S. Code of Federal Regulations, Part 812.5 for investigational devices;
Title 21 of the U.S. Code of Federal Regulations, Part 820 for design and manufacturing controls for labeling; and
Title 21 of the U.S. Code of Federal Regulations, Part 1010 ­ Performance standards for electronic products. Also see Parts 1020 and 1040.
Section 201(k) of the FD&C Act defines the term "label" as "a display of written, printed, or graphic matter upon the immediate container of any article . . . ." Under Section 201(l) of the FD and C Act, the term "immediate container" does not include a package liner. Any word, statement, or other information appearing on the immediate container should also appear on the outside container or wrapper, if any, of the retail package or be easily legible through the outside container or wrapper. The label is not required to appear on the shipping carton.
Section 201(m) of the FD&C Act defines the term "labeling" as all labels and other written, printed, or graphic matter: (1) on the device or any of its containers or wrappers, or (2) accompanying the device. The term applies any time while the article is in interstate commerce, or being held for sale after shipment or delivery in interstate commerce. The term "accompanied" is interpreted liberally. It extends to posters, tags, pamphlets, circulars, booklets, direction sheets, fillers, etc., that may be displayed in proximity to the article or shipped to the user before or after shipment of the device.
The distinction between labeling and advertising, while both draw attention to the article to be sold, is often nebulous or superficial. Both are forms of publicity and are used for an identical purpose. An appellate court described the relationship between the two as follows: "Most, if not all, labeling is advertising. The term 'labeling' is defined in the Act [section 201(m)] as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from this definition printed matter which constitutes advertising."
Section 502(f)(1) and (2) of the FD&C Act requires that device labeling bear adequate directions for use, operating and servicing instructions, and either adequate warnings against uses dangerous to health, or information necessary for the protection of users. All devices require directions for use unless specifically exempted by regulation. Conditions for exemption from this requirement are in 21 CFR 801, Subpart D.
Section 502 of the FD&C Act contains the misbranding provisions for drugs and devices. It states a device is misbranded under a number of different circumstances, including:
Its labeling is false or misleading.
Its packaging does not bear a label containing the name and place of business of the manufacturer, packer, or distributor, and an accurate statement of the quantity of contents.
Words, statements, or other required information are not prominent on the labeling or are not stated clearly.
It is intended for human use, and the label fails to bear the name and quantity or proportion of any narcotic or habit­forming substance contained in the product, and fails to display the statement, "Warning: may be habit forming."
Its label does not contain adequate directions for use. These include warnings against use in certain pathological conditions; against use by children where its use may be dangerous to health; and against unsafe dosage, methods, duration of administration or application unless exempt as unnecessary to protect the public health.
It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.
It does not comply with the color additive provisions listed under Section 706 of the FD&C Act.
The Medical Device Amendments expanded the authority of the FD&C Act over misbranded medical devices. These amendments contain further circumstances under which a device is misbranded:
The device's established name (if it has one), name in an official compendium, or including common or usual name, is not printed prominently in type at least half as large as used for any proprietary name.
The device is subject to a performance standard and it does not bear the labeling requirements prescribed in that standard.
There is a failure or refusal to comply with any requirement prescribed under Section 518 on notification and other remedies; failure to furnish material or information requested by or under Section 518; or failure to furnish any materials or information requested by or under Section 519 on records and reports.
The device is commercially distributed without FDA concurrence on a 510(k) premarket notification submission.
Section 502(a) states that a drug or device is misbranded if its labeling proves false or misleading in any particular. It is not a necessary condition that t