Establishments listing 10 or more SUDs

Contains Nonbinding Recommendations

Guidance for Industry and
FDA Staff
Compliance with Section 301 of the
Medical Device User Fee and
Modernization Act of 2002, as amended
– Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices
Document issued on: May 1, 2006
The draft of this document was issued on October 11, 2005.
The information collection provisions in this guidance have been approved under OMB
control number 0910-0577. This approval expires 5/31/2018. See additional PRA statement
in Section IX of this guidance.
For questions regarding this document contact Casper Uldriks at the Center for Devices and
Radiological Health (CDRH) at 240-276-0106, or at [email protected].

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance

Contains Nonbinding Recommendations

Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to
the exact title of this guidance document. Comments may not be acted upon by the Agency
until the document is next revised or updated.

Additional Copies
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/comp/guidance/1217.pdf or to receive this document by fax, call the
CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a
document. Enter the document number 1217 followed by the pound sign (#). Follow the
remaining voice prompts to complete your request.

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Guidance for Industry and FDA Staff
Compliance with Section 301 of the Medical
Device User Fee and Modernization Act of
2002, as amended – Prominent and
Conspicuous Mark of Manufacturers on
Single-Use Devices
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.
It does not create or confer any rights for or on any person and does not operate to bind FDA or the
public. You can use an alternative approach if the approach satisfies the requirements of the
applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff,
call the appropriate number listed on the title page of this guidance.

I. Introduction
On October 26, 2002, section 301 of the Medical Device User Fee and Modernization Act of
2002 (MDUFMA) (Public Law 107-250) amended section 502 of the Federal Food, Drug,
and Cosmetic Act (the Act) to require a device, or an attachment to the device, to bear
prominently and conspicuously the name of the manufacturer, a generally recognized
abbreviation of such name, or a unique and generally recognized symbol identifying the
manufacturer. An important revision was made to section 502(u) of the Act by the Medical
Device User Fee Stabilization Act of 2005 (MDUFSA) (Public Law 109-43), which became
law on August 1, 2005.
MDUFSA amended section 502(u) by limiting the provision to reprocessed single-use
devices (SUDs) and the manufacturers who reprocess them. Section 502(u) no longer sets
forth requirements for original equipment manufacturers (OEMs), unless those
manufacturers also reprocess single-use devices. Under the amended provision, if the
original device or an attachment to it does not prominently and conspicuously bear the name
of the manufacturer of the original device, a generally recognized abbreviation of such name,
or a unique and generally recognized symbol identifying the manufacturer, the manufacturer
who reprocesses the SUD may identify itself using a detachable label on the device’s
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packaging. The detachable label is intended to be affixed to the medical record of a patient
by the user of the reprocessed SUD.
MDUFSA also requires that FDA issue guidance identifying the circumstances in which the
name, abbreviation, or symbol of the manufacturer of an original device is not “prominent
and conspicuous” under section 502(u) of the Act. On October 11, 2005, FDA issued draft
guidance describing these circumstances. In addition, because section 502(u) requires that a
reprocessed SUD or its attachment prominently and conspicuously bear the name of the
reprocessor, except as described above, the document also provided guidance for
reprocessors to determine whether their names, abbreviations, or symbols placed on the
reprocessed SUDs are prominent and conspicuous.
MDFSA requires that FDA issue this guidance not later than 180 days after the date of
enactment (August, 1, 2005). Therefore, the agency requested that interested persons submit
their comments on the draft guidance within 30 days of its issuance. As discussed below,
FDA received comments on the draft, all of which were considered in finalizing the
guidance.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidance documents describe the Agency's current thinking on a
topic and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance documents means
that something is suggested or recommended, but not required.

The Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of medical device
regulation. This guidance reflects our careful review of the relevant scientific and legal
requirements and what we believe is the least burdensome way for you to comply with those
requirements. However, if you believe that an alternative approach would be less
burdensome, please contact us so we can consider your point of view. You may send your
written comments to the contact person listed in the preface to this guidance or to the CDRH
Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to
contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.

II. Consultation with Stakeholders
FDA received comments from stakeholders, all of which were considered in developing this
guidance. Each stakeholder who responded provided comments on the effective date for
implementing the reprocessor labeling requirement. MDUFSA identifies two effective dates
for compliance with section 502(u) of the Act.
The first effective date is August 1, 2006, which is 12 months after the date of enactment on
August 1, 2005. This date applies to those reprocessed SUDs for which the OEM first
marked the original device in a prominent and conspicuous manner before August 1, 2006.
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This date also applies to devices that are not marked or do not include an attachment with the
OEM's name, as well as to devices which are marked or do include an attachment, but do not
prominently and conspicuously bear the name of the OEM. Under section 502(u), the
reprocessor may use a detachable label on such devices. Therefore, for all devices that are
reprocessed and introduced or delivered for introduction into interstate commerce after
August 1, 2006, the reprocessor must either mark the device, place its mark on an
attachment, or where applicable, it may instead place its mark on a detachable label.
The second effective date relates to compliance in those situations where the OEM first
marks its device after August 1, 2006. Two comments questioned this second effective date.
The draft guidance provided that once the OEM marks the device, the reprocessor must mark
the device, use an attachment, or where applicable, a detachable label. The comments argued
that if the OEM marked its device after August 1, 2006, the reprocessor of the SUD should
still have 12 months from the date on which the OEM first marked the device in which to
mark the reprocessed device.
The statutory language in MDUFSA regarding the effective dates states that section 502(u)
shall be effective with respect to reprocessed SUDs "12 months after the date of enactment of
the Medical Device User Fee Stabilization Act of 2005, or the date on which the original
device first bears the name of the manufacturer of the original device, a generally recognized
abbreviation of such name, or a unique and generally recognized symbol identifying such
manufacturer, whichever is later." (emphasis added). The statutory language does not
provide for an additional 12 month period for the reprocessor to mark the device where the
OEM first marks its product after August 1, 2006. The statutory language is clear that when
an OEM prominently and conspicuously marks its device for the first time after August 1,
2006, the reprocessor -- who must have already identified itself through a detachable label as
of August 1, 2006 if it did not mark the device or use an attachment -- does not get an
additional 12 months in which to put its mark on the device itself.
The statutory language that requires the reprocessor's mark on "the date on which" the OEM
first marks the device will give health care providers necessary information so they can
report device related adverse events accurately and promptly to FDA. Mistakes in reporting
and failures to make reports due to the inability to identify the correct manufacturer of a
reprocessed single-use device undermine the agency’s postmarket surveillance program.
Moreover, FDA believes that procedures for implementing compliant labeling specifications,
among other manufacturing requirements, should already be established and implemented
under a reprocessor’s Quality Systems (QS) program, as required by 21 CFR Part 820.
In addition to the above comments on the effective date, one comment questioned whether
the statute requires that the detachable label be placed in the patient record. The statutory
language clearly indicates that a detachable label is intended to be affixed to the medical
record of the patient under section 502(u)(2), as amended.
One commenter requested that FDA include guidance on whether the mark of the
manufacturer of the original device should be required to be obliterated by the reprocessor
when placing its mark on the SUD. This comment also requested an exemption from device
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marking be permitted for comparative study purposes and that such studies not be considered
to pose a significant risk under the Investigational Device Exemptions regulation (21 CFR
812). These issues fall outside the scope of this guidance and, therefore, are not addressed in
this guidance.
The agency carefully considered all of the above comments. As discussed above, however,
the information published in the draft guidance remains unchanged in this final guidance.

III. Definitions
For the purposes of this guidance, FDA has defined the following terms:
Attachment: An article secured to a device in such a way that it cannot be removed
inadvertently.
Detachable label: A removable label on the device packaging that identifies the
manufacturer who reprocessed the SUD and is intended to be affixed to the patient record.
Mark: A name, generally recognized abbreviation of such name, or a unique and generally
recognized symbol that identifies a particular manufacturer.
Prominent and conspicuous: A manner of marking a device, as required by section 502(u)
of the Act, such that the manufacturer’s mark is apparent to the user under ordinary
conditions of use.
Reprocessor: A manufacturer who subjects a previously used SUD to additional processing
and manufacturing for the purpose of an additional single use on a patient.
Single-Use Device: A device that is intended for one use, or on a single patient during a
single procedure.

IV. Who Does this Guidance Cover?
This guidance applies to all manufacturers who reprocess single-use devices; therefore, it
also applies to OEMs who reprocess SUDs.

V. How Do I Know Whether the Mark of a Manufacturer is Prominent and
Conspicuous?
A. We recommend considering the following factors when deciding whether a manufacturer’s
mark is prominent and conspicuous:
1. Available space on the device itself
2. Contrast

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3. Meaning
4. Font or Graphic Readability
B. You may use the following information and examples to help you decide whether a
manufacturer’s mark is prominent and conspicuous based on the above:
1. Available space: Is there enough space for the manufacturer’s mark so that it can
be recognized under ordinary conditions of use, such as in an operating room,
emergency room, or ambulance?
For example:
The area of space the size of the side of a common ink pen would likely be
adequate to display the mark of the manufacturer.
The area of space the size of the head of a common thumbtack would likely not be
adequate to display the mark of the manufacturer.
2. Contrast: We recommend that the difference between the color of the
manufacturer’s mark and the color of the background should make the
manufacturer’s name or mark apparent to the user under ordinary conditions of
use.
For example:
A manufacturer’s name using a dark color against a light background creates a
contrast that should make the identification apparent.
A manufacturer’s name using a light color against a background that is different
but not very much darker in color will make it less likely that the identification
will be apparent under ordinary conditions of use.
3. Font or Graphic Readability: Is the style of the text easy to read and large
enough to see during ordinary conditions of use? The actual print and size of the
name should be sufficiently clear to enable it to be read under ordinary conditions
of use.
For example:
Newspapers, magazines, business letters, or mass media advertisements use a size
and style of type that users can read easily.
Office pens usually bear the mark of the manufacturer or vendor. The name on
the pen is large enough so the user can read it while using the pen.

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A script that is so ornate or elaborate that the name cannot be easily read will
likely make the essential information less readable.
4. Meaning: Will the user understand the manufacturer’s mark that appears on
the product?
Assuming that the manufacturer has considered available space, contrast, and
readability, FDA believes the full name of the manufacturer will be
understandable during ordinary conditions of use. When a manufacturer uses an
abbreviation of the name, or a symbol, instead of the full name, the manufacturer
should use an abbreviation that is closely related to the full name or a unique and
recognizable symbol that is associated with the manufacturer.
For example:
When a product bears a manufacturer’s name, such as “American Business
Company, Inc.,” or “XYZ, Inc.,” the user should be able to identify the
manufacturer.
When a product manufactured by the Long Reprocessing Corporation is identified
with the word “Long,” the agency believes that the manufacturer will be
identifiable under ordinary conditions of use.
When a product bears a unique mark that is generally recognized and associated
with the manufacturer, such as an emblem or hood ornament on a car, the user
should be able to identify the manufacturer under ordinary conditions of use.
A mark that is generic or not easily identified with a particular manufacturer, such
as a hollow circle, will probably not help a user identify the manufacturer.
Note: We also recommend that you consider this factor in determining whether an
abbreviation or symbol is "generally recognized" under section 502(u) of the Act.

VI. When is this New Labeling Requirement Effective?
The requirement that a reprocessed SUD, or an attachment to the SUD, must bear the
reprocessor’s mark is effective on one of the following dates, whichever is later:
1. August 1, 2006, which is 12 months after the law was enacted on August 1, 2005
E.g., if the original device or an attachment to it bears the OEM’s mark
prominently and conspicuously on July 1, 2006, then the reprocessed SUD or its
attachment must prominently and conspicuously bear the mark of the reprocessor
no later than August 1, 2006.
OR
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2. The date, after August 1, 2006, on which the original device or an attachment to it first
bears the OEM’s mark prominently and conspicuously. If the original device or an
attachment to it did not prominently and conspicuously bear the OEM's mark prior to
August 1, 2006, but does so at any later date, then the reprocessed SUD or its attachment
must prominently and conspicuously bear the mark of the reprocessor before the
reprocessed device may be legally marketed.
For example, if the original device first prominently and conspicuously bears the
OEM's mark on September 1, 2006, at that point in time a reprocessor must
prominently and conspicuously use its own mark on the reprocessed device or its
attachment before marketing.
After August 1, 2006, even if the original device or an attachment to it does not bear the
OEM’s mark (the OEM’s mark is absent or is not prominent and conspicuous), the
reprocessed SUD must identify the reprocessor. Under this circumstance, the reprocessor
may identify itself through use of a detachable label on the packaging of the SUD, as
described below.

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VII. When Should a Reprocessor Place its Mark on a Device, Use a
Detachable Label, or Use an Attachment?
According to section 502(u) of the Act, a reprocessed SUD, or an attachment to it, must
prominently and conspicuously bear the name of the manufacturer of the reprocessed device,
a generally recognized abbreviation of the name, or a unique and generally recognized
symbol identifying such manufacturer. The only exception to this requirement is when the
original device, or an attachment to it, does not prominently and conspicuously identify the
name of the original equipment manufacturer, a generally recognized abbreviation of the
name, or a unique and generally recognized symbol identifying such manufacturer. Under
this circumstance, the reprocessor may use a detachable label on the packaging to identify
the manufacturer of the reprocessed device.
As stated in MDUFSA, the detachable label is intended to be affixed to the medical record of
a patient. FDA therefore recommends that this label contain a statement directing a
practitioner to remove the detachable label and affix it to the patient’s medical record when
the reprocessed SUD is used.
If the original equipment manufacturer has marked the device in such a way that there is little
or no usable space for a reprocessor to prominently and conspicuously mark the device, the
reprocessor may satisfy the labeling requirement of section 502(u) through the use of an
attachment to the device.
The following flow chart should help you decide whether you should place your mark on the
device, use a detachable label, or use an attachment.

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REPROCESSOR’S DECISION FLOW CHART
DO I PLACE MY MARK ON THE DEVICE, USE A DETACHABLE LABEL, OR
USE AN ATTACHMENT?*

Did the OEM mark
the original device at
all?

NO

YES

NO

Is the mark
prominent and
conspicuous?
YES

Is there usable
space for the
reprocessor to
label the device?

NO

YES

Reprocessor must be
identified through a
mark on the device or
on an attachment.

Reprocessor must be
identified; can be
done using a
detachable label.

Reprocessor must
be identified; can
be done using an
attachment.

*Section 502(u) of the Federal Food, Drug, and Cosmetic Act, as amended.

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VIII. Can a Reprocessor Obtain a Waiver from this Labeling
Requirement?
No. Section 502(u) does not provide for a waiver from the labeling requirement.

IX.

Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 0.1 hours
per response, including the time to review instructions, search existing data resources, gather
the data needed, and complete and review the information collection. Send comments
regarding this burden estimate or suggestions for reducing this burden to:
FDA PRA Staff,
Office of Operations,
Food and Drug Administration,
[email protected]

An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The
OMB control number for this information collection is 0910-0577, expires 05/31/2018.

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