Label vs labelling
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Section 201(k) defines 'label' as a: |
Section 201(m) defines 'labeling' as: |
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'display of written, printed, or graphic matter upon
the immediate container of any article...' |
'all labels and other written, printed, or graphic
matter upon any article or any of its containers or
wrappers, or (2) accompanying such article' at any time while a
device is held for sale after shipment or delivery for shipment in interstate
commerce |
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The term 'immediate container' does not include package
liners. Any word, statement, or other information
appearing on the immediate container must also appear 'on the outside
container or wrapper, if any there be, of the
retain package of such article, or is easily legible through the outside
container of wrapper.' |
The term 'accompanying' is interpreted liberally
to mean more than physical association with the product. It extends to posters,
tags, pamphlets, circulars, booklets, brochures, instruction books, direction
sheets, fillers, etc. 'Accompanying' also includes labeling that
is brought together with the device after shipment or delivery for shipment
in interstate commerce. |
21 CFR 801 General Device Labelling
21 CFR 801.1:
– Name and place of manufacturer, packer or distributor
– Including the street address, city, state and zip code
21 CFR 801.5: Adequate directions for use under which the layman can use a device safely for intended purposes
21 CFR 801.15: Required information must be displayed prominently on
label. Exempted where device labelling lacks sufficient space.
All labeling shall be
in English with the exception of products distributed solely within Puerto Rico
or a U.S. territory where the predominant Ianuage is other than English.
21 CFR 801.109: A prescription device is exempt from “adequate directions for use”, provided:
– Device is in possession of a licensed practitioner
– Labeling has a Rx statement
– Labeling includes information for use
– Common use is known to the ordinary individual
Subpart H - Special
Requirements for Specific Devices
21 CFR 801.15 Symbols used in labelling.
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In Vitro Diagnostic
Products - 21 CFR Part 809
LABEL REQUIREMENTS FOR
THE IMMEDIATE CONTAINER
The label for IVD's
must state the following information, except in cases where it is
not applicable.
·
The established and
proprietary names of the product, e.g., cholestrolometers;
·
The
intended use or uses, e.g., pregnancy detection, diabetes screening, etc.
·
A
statement of warnings or precautions for users listed in 16 CFR part
1500 (hazardous substances) and any other warnings appropriate to user hazards,
and a
statement
"For In Vitro Diagnostic Use;"
·
Name and place of
business of the manufacturer, packer, or distributor
·
Lot or control number
For Reagents:
·
Established
(common or usual) name;
·
Quantity,
proportion, or concentration of all active ingredients:
·
Storage instructions, i.e., temperature,
humidity, etc.
·
Instructions
for manipulation of products requiring mixing or reconstitution
·
Means to
assure that the product meets appropriate standards of purity, quality,etc., at
the time of use, including one or more of the following:
· expiration date (date beyond which the product is not
to be used);
· statement of any visual indication of alteration;
· instructions for a simple check to assure product
usefulness;
·
The net
quantity of contents.
If the immediate containers are too small, or no sufficient space, then the
required labeling as listed above with blue text may appear on the outer
container labeling only.
LABELING REQUIREMENTS
FOR INSERTS AND OUTER PACKAGING [809.10(B)]
·
The
proprietary and established product name;
·
The
intended use of the product and whether it is a qualitative or quantitative
type of procedure, e. g., screening,
physician's office, home use, etc.
·
Summary
and explanation of the test, including a short history containing methodology
and the special merits and limitations of the test
·
The
chemical, physical, physiological, or biological principles of the procedure
For Reagents:
· The common name, if any, and quantity, proportion, or concentration or each
· reactive ingredient; and for biological materiar, the source and measure of its activity.
· Appropriate cautions or warnings listed in 16 CFR Part 1500; the statement: "For
In Vitro Diagnostic Use;" and any other limiting statements appropriate to the intended use of the product;
· Adequate directions for reconstitution, mixing, dilution, etc.
· Appropriate storage instructions
· A statement of purification or treatment required for use; and
· Physical, biological, or chemical indications of instability or deterioration.
For Instruments:
· Use or function.
· Installation procedures and requirements
· Principles of operation
· Performance characteristics and specifications
· Operating instructions
· Calibration procedures, including equipment and or materials
· Operational precautions and limitations
· Hazards
· Service and maintenance information.
Specimen collection and preparation for analysis, describing:
· Special precautions/preparations
· Additives necessary to maintain specimen integrity
· Known interfering substances; and
· Recommended specimen storage, handling, and shipping instructions
· Explanation of the procedure
· Limitations of the procedure
· Expected values including the range and how it was established
· Specific performance characteristics as appropriate including accuracy, specificity,
· precision, and sensitivity
· Bibliography
· Name and place of business of the manufacturer, packer, or distributor
Premarket submissions 510(k) ,IDE and
PMA have specific labelling requirements.
Modernization Act (MDUFMA))
References:
Device Labeling:
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
Labeling - Regulatory Requirements forMedical Devices
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