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820.120
Device labeling.
Each
manufacturer shall establish and maintain procedures to control labeling
activities. (a) Label
integrity. Labels shall be printed and applied so as to remain legible
and affixed during the customary conditions of processing, storage, handling,
distribution, and where appropriate use. (b) Labeling
inspection. Labeling shall not be released for storage or use until a
designated individual(s) has examined the labeling for accuracy including,
where applicable, the correct expiration date, control number, storage
instructions, handling instructions, and any additional processing
instructions. The release, including the date and signature of the
individual(s) performing the examination, shall be documented in the DHR. (c) Labeling
storage. Each manufacturer shall store labeling in a manner that provides
proper identification and is designed to prevent mixups. (d) Labeling
operations. Each manufacturer shall control labeling and packaging
operations to prevent labeling mixups. The label and labeling used for each
production unit, lot, or batch shall be documented in the DHR. (e) Control
number. Where a control number is required by § 820.65, that control
number shall be on or shall accompany the device through distribution. The following
labeling overview has been taken from the FDA’s website (http://www.fda.gov/cdrh/devadvice/334.html):
Interpretation:
Medical device manufacturers must incorporate in
their quality assurance (QA) program several elements that relate to labeling
in order to meet the Good Manufacturing Practice (GMP) requirements of the
Quality System regulation. The QA program must be adequate to ensure that
labeling meets the GMP device master record requirements with respect to
legibility, adhesion, etc., and ensure that labeling operations are
controlled so that correct labeling is always issued and used. Labeling includes equipment labels, control labels,
package labels, directions for use, maintenance manuals, etc. The displays on
CRT's and other electronic message panels are considered labeling if
instructions, prompts, cautions, and parameter identification information are
given. Various sections of the QS regulation have an
impact on labeling: Section 21
CFR 820.80(b) requires the inspection and testing of incoming materials
including labeling; and 21
CFR 820.70(f) requires buildings to be of suitable design and have sufficient
space for packaging and labeling operations. 21
CFR 820.120 deals with specific requirements for the control of labeling.
It applies to the application of labeling to ensure legibility under normal
conditions of use over the expected life of the device; and also applies to
inspection, handling, storage, and distribution of labeling. FDA considers a
device to be adulterated if these requirements are not met. These
requirements do not apply to the adequacy of labeling content, except to make
sure the content meets labeling specifications contained in the device master
record. However, failure to comply with GMP requirements, such as
proofreading and change control, could result in labeling content errors. In
such cases, the device is misbranded and adulterated. Specifications are required in the design history
file (DHF) 21
CFR 820.30 for the content and physical design parameters of labels.
Labeling specifications are: engineering drawing and/or artwork for each
label, appropriate inspection or control procedures, and appropriate
procedures for attaching the labels. All procedures, drawings, and artwork
must have the name of the preparer, an approval signature, and a date. The
approval signature, date, etc., may be on the backside of artwork or on a
label approval form. Further, artwork may contain only an identification code
or title if the "content" of the artwork is duplicated on approved
engineering drawings or adequately identified (cross-referenced) with respect
to the label approval form. Hard copy labels, package inserts, and similar
labeling are specified and purchased as components. For correct purchase and
use of labeling, specifications are usually stated on engineering drawings
and/or purchase specifications. Thus, artwork or "copy" alone will
not fulfill the device master record requirements for labeling except for the
most simplistic labeling such as brief errata sheets. The engineering drawings or purchase specifications
and mounting procedure must specify, as appropriate, the label substrate,
dimensions, ink, finish, mounting method, etc., so that the purchased label
will remain attached and legible during the customary conditions of
processing, storage, handling, distribution, and use. Front panels, other instrument panels, meters,
fuses, pushbuttons, and the like often are labels or contain labels and must,
as appropriate, meet device master record and control requirements. Component
specifications, assembly drawings, and test/inspection procedures may be
appropriate controls to prevent mixup of meters, pushbuttons, and other
labeled instrument controls. Controls to prevent mixups are generally not
needed for front and other instrument panels. Whether a firm considers a software driven display
to be labeling or data makes little difference under the Quality System
regulation, because either way, the finished device labeling or data must
meet the device master record specifications. When firms develop and validate
software, they should also review these electronic displays to see that the
"labeling" meets all applicable requirements, such as adherence to
specifications in the device master record, correct parameter identification,
agreement with the instruction manual, and of course, correct display of
performance data. When reviewing or auditing labeling operations, it
is wise to keep in mind that the Quality System regulation contains flexible
requirements and thus allows flexibility in a quality assurance program. The
degree of labeling control needed to satisfy the Quality System regulation
varies considerably for different devices and operations. In order to avoid
wasting money and increasing the cost of health care, manufacturers need to
give considerable and prudent thought to the appropriate level of control
needed for their operations. Information and guidelines presented in this
chapter should aid manufacturers in making these decisions. The level of
control needed should be reconsidered when products are added or changed.
Likewise, the controls needed and success of the existing control program
must be reviewed during QA system audits.
Label Integrity All labels must be designed and applied to devices
and containers so that the labels will remain in place and legible during the
customary conditions of distribution, storage, and use. Likewise, other
labeling, such as user instructions, should remain legible during customary
storage and use. For example, labeling printed by machines onto plastic in
vitro diagnostic media plates is sometimes smeared and thus is inadequate
[FD&C 502(f)]. The manufacturers of such devices must assure that the
print is legible and will remain legible until used. Receipt and inspection Upon receipt, all packaging and labeling materials,
including preprinted containers, inserts, and preprinted packaging materials
must be examined and, acceptance activities performed to assure conformance
with specifications. Also, samples of labels must be proofread by a
designated individual(s). After being accepted by a responsible individual,
these components may be placed into inventory or into production. These
acceptance activities must be recorded in the device history record as
required by 21
CFR 820.80(e) and 21
CFR 820.120 to show that inspection and proofreading were performed. The
acceptance record for device labeling should be kept simple. Area Separation and Inspection All labeling and packaging operations should be
separated to the degree necessary to make certain there are no mixups between
similar products or labels. Separation may be either a physical or spatial
separation or by performing the labeling and packaging at different times for
different devices. Separation is not required when mixups are impossible such
as the case of labels from panels that fit the intended family or instruments
(devices). The likelihood of a labeling mixup determines how
stringent production area controls should be. For example, label control need
not be stringent if only dissimilar products and labeling are processed.
Before beginning any packaging and labeling operation in which mixup could
occur, the production area and equipment for the operation must be thoroughly
examined to make certain that any devices and labeling materials remaining
from previous operations have been removed. It is important to make certain
that the surrounding area, tables, packaging lines, printing machines, and
other equipment are cleared of labels and other materials used in the previous
operation. Unused labeling that contains pre-coded serial
numbers, manufacturing date, expiration date, control number, etc., should be
destroyed and not returned to the label storage area. The Quality System
regulation does not require reconciliation of the number of labels used
versus the number issued, although this control is recommended for some
devices, such as when different sizes of the same product are being packaged
or otherwise labeled. Storage All printed packaging and labeling materials,
including preprinted containers, inserts and preprinted packaging materials,
must be stored in an area and manner suitable to prevent mixups (21
CFR 820.120). Labeling should be identified and segregated to the degree
necessary to prevent mixing of similar labeling. Access to labeling should be
limited to authorized personnel. Storage control should be appropriate for the
number and kind of devices. For example, a firm that manufacturers only one
product with one label does not need an elaborately controlled storage area.
Similarly, a firm with only a few types of devices having dissimilar labeling
would not normally require stringent control. One case that requires dedicated attention to
storage and control is prelabeled "sterile" but
"not-yet-sterilized" devices. Firms must make certain that mixups
cannot occur. Also make certain that all such samples, if used for market
promotion, are sterile or stamped with a manifest caution statement because a
package and labeled market-promotion sample might be used by the recipient. Label Check and Record When issued for use, labeling must be carefully
examined to make certain the contents of the labeling comply with the
labeling specifications in the device master record for the specific device
being produced. This examination must include any control numbers or
expiration dates used on the labels. A record of this issuance check,
including the date and name of the person performing the examination, must be
made in the device history record. If used, expiration dates must reflect the time
after final packaging during which the device is fit for its intended use
when stored and used per its labeling. The manufacturer should have stability
test data which establishes the interval that the device remains fit for use.
If label mixups cannot occur--for example, a firm
makes only one device or uses only one label--and there are no control
numbers or expiration dates, the original inspection when the labeling was
placed into inventory is an adequate check for compliance with the device
master record specifications. Changes Labeling is part of the device master record;
therefore, all changes to labeling must be made under a formal change control
system similar to that required for specifications [21
CFR 820.30(i)]. Any changes to labeling must be formally reviewed and
authorized before implementation. When making changes to primary aspects of a device
and to primary documentation, the review group must determine if any
secondary items such as labels or instructions are affected and also need
changing. There should be a check-off block on change-order forms for
recording that the effect of the primary change on labeling was considered
and appropriate action was taken. Relabeling and Over-labeling Over-labeling by placing a new label over an old
label is discouraged by FDA but is acceptable as long as the new label and
its use meet GMP requirements for attachment, legibility, reprocessing, and
change control. (Over-labeling is also discouraged in some foreign
countries.) Control Number Devices intended for surgical implant into the body
or to support or sustain life and whose failure to perform when properly used
in accordance with instructions for use provided in the labeling can be
reasonably expected to result in a significant injury to the user require a
control number on each unit, lot, or batch of finished devices and where
appropriate components for traceability [21
CFR 820.65]. This means a control number for the finished device, and not
the label itself. Most labeling, however, also contains another number, such
as a drawing number, for control of labeling configuration and procurement. The control number for traceability need not be on
every label on the device; however, the control number must appear on the
unit label that goes to the ultimate user. The label on a shipping carton for
bulk items does not meet this requirement because bulk items may go to
central distribution point in the user-facility and the shipping carton would
most likely be discarded. In order to meet this traceability requirement, a
label that would most likely reach the nurse or other user station must have
the control number.
Special attention should be given to the labeling
of sterile devices. Devices that are not sterile in their entirety (for
example, sterility may be needed only for the lumen of certain devices) must
be labeled to properly inform users what is actually intended to be
"sterile" in the package. For example, a possible limiting
statement might be: "Caution: Only the fluid path of the set is
sterile and non pyrogenic. Do not use in a sterile or aseptic area without
proper precautions." Some devices are intended to be sterilized by the
user before use. In this situation, the labeling should provide adequate
information as to at least one suitable method of sterilization and any
precautions or safeguards to be followed. For example, the labeling should
describe any:
In the case of single-use sterile devices, some
manufacturers include labeling to advise against resterilization and reuse.
Some devices are simply not designed or constructed to be recleaned, and may
not be capable of withstanding the necessary recleaning and resterilization
procedures. Where reuse is common practice, manufacturers are encouraged to
provide the information described in the above list. The label of multi-device kits or packages
containing a combination of sterile and nonsterile products must not state or
imply that all contents are sterile. The need for users to have instructions on how to
open a sterile device package to avoid contamination of the device also needs
to be evaluated, and when necessary, such instructions should be included in
the labeling. When a manufacturer modifies a device, the
manufacturer must also review the labeling to make certain that it reflects
current revisions and specifications. Some manufacturers identify labeling
with a drawing number plus a revision code or date as an aid in identifying
current labeling. The package insert or other labeling for in vitro
diagnostic products is required to contain the revision date [21
CFR 809.10(b)(15)]. Shelf-life dating solely for package integrity and
sterility is not usually required by FDA for general medical devices. There
may be a need for expiration dating when a particular component of a device,
such as a battery or diagnostic reagent, has a finite useful life. Labeling
for in vitro diagnostic devices [21
CFR 809.10(a) and (b)] requires an expiration date or some other means by
which users may be assured of quality at the time of use. This requirement
applies to both sterile and nonsterile in vitro diagnostic devices. Although not always required by regulation, most
manufacturers of complex devices and sterile devices voluntarily use lot or
serial numbers for production control and, if the need arises, to expedite
failure investigations, repairs, modifications, or recalls. Lot, batch, or
other control numbers are required for:
Adequate labeling for a medical device requires
proper design and procurement of the labels and labeling. Design includes
labeling content that meets the requirement of the QS regulation as well as
the needs of the customer. To achieve these goals a number of concepts must
be kept in mind such as: writing to the reader, referring to the actual
device in labeling, obvious identification of the controls used, etc.
Finished devices that are terminally sterilized by
a firm other than the manufacturer pose a unique labeling problem. A common
industry practice is to send the finished device in its final packaging to a
contractor for sterilization. The final packaging is labeled as sterile even
though the goods are unsterile during shipment from the manufacturer to the
contractor. Specific restrictions apply in this instance, and a written
agreement between the parties must be in effect [21
CFR 801.150(e)]. The requirements for the labeling of in process sterile
goods in transit to the contract sterilizer are addressed in detail by 21
CFR 801.150, and covered under Other Labeling Exemptions.
Care must be taken in this situation to eliminate the possibility of an
unsterilized product being mistaken for a sterilized product. A firm should
seriously consider the use of "visual indicator" labeling to
distinguish between product before and after sterilization, e.g., the use of
indicator tape with bands that develop color upon exposure to steam or
ethylene oxide, or stick-on "dots" which change color upon exposure
to radiation. Bear in mind that visual indicators will provide confidence
that the product has been exposed to a sterilant and not that the product is
sterile. A firm should also consider the use of dosimeters, i.e., a product
that undergoes an irreversible change in physical or chemical properties that
is proportional to the amount of exposure to a sterilant. Some contract
sterilizers affix labeling to a contractor's product in the form of a
sterilization number stamped upon the device container, or outer shipping
containers. Firms who use the contract sterilizer's lot number as assurance
that their devices have undergone sterilization should determine, via an
audit of the facility if possible, that sterilization lot numbers are applied
after, not before, being subject to sterilization. Regulations on distribution are contained in 21 CFR
801, Subparts A and E; and Quality Systems Regulation 21
CFR 820.160. Devices that have been sterilized, held, or shipped to the
manufacturer's warehouse or other controlled distribution point before final
release must be properly labeled. The pallets, or designated unit, must be
marked to indicate the status of the device such as "sterilized:
awaiting test results," or an equivalent statement. The company must be
able to show that it has control of the devices until final release and, if
necessary, could have them destroyed or returned for reprocessing. For this
reason, a distributor's warehouse or facility is not considered a controlled
distribution point. Information on
other labeling issues |
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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