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 casper.uldriks@fda.hhs.gov. 
 
 
 
 
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.   
 
 
  2 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 
 
 
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 devices 
  1 Contains Nonbinding Recommendations 
 
 
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.  
  2 Contains Nonbinding Recommendations 
 
 
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 agencys 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 reprocessors 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 
  3 Contains Nonbinding Recommendations 
 
 
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 manufacturers 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 manufacturers 
mark is prominent and conspicuous: 
 
1.  Available space on the device itself  
2.  Contrast 
  4 Contains Nonbinding Recommendations 
 
 
3.  Meaning 
4.  Font or Graphic Readability 
 
B.  You may use the following information and examples to help you decide whether  a 
manufacturers mark is prominent and conspicuous based on the above: 
 
1.  Available space: Is there enough space for the manufacturers 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 
manufacturers mark and the color of the background should make the 
manufacturers name or mark apparent to the user under ordinary conditions of 
use. 
 
For example: 
 
A manufacturers name using a dark color against a light background creates a 
contrast that should make the identification apparent. 
 
A manufacturers 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.  
 
  5 Contains Nonbinding Recommendations 
 
 
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 manufacturers 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 manufacturers 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 
reprocessors 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 OEMs 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 
  6 Contains Nonbinding Recommendations 
 
 
 
2.  The date, after August 1, 2006, on which the original device or an attachment to it first 
bears the OEMs 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 
OEMs mark (the OEMs 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. 
 
  7 Contains Nonbinding Recommendations 
 
 
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 patients 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.  
  8 Contains Nonbinding Recommendations 
 
 
 
REPROCESSORS DECISION FLOW CHART  
DO I PLACE MY MARK ON THE DEVICE, USE A DETACHABLE LABEL, OR 
USE AN ATTACHMENT?* 
Did the OEM mark 
NO
the original device at 
all? 
YES 
Is the mark  NO
prominent and 
conspicuous?  
YES 
Is there usable 
space for the 
NO
reprocessor to 
label the device?
YES 
Reprocessor must be  Reprocessor must be  Reprocessor must 
identified through a  identified; can be  be identified; can 
mark on the device or  done using a  be done using an 
on an attachment. detachable label. attachment. 
 
 
  
*Section 502(u) of the Federal Food, Drug, and Cosmetic Act, as amended. 
 
  9 Contains Nonbinding Recommendations 
 
 
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, 
PRAStaff@fda.hhs.gov 
 
 
 
 
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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