Guidance for Industry and FDA Staff 
Frequently Asked Questions (FAQs) 
on the Status of Reprocessed Single 
Use Devices (SUDs) that receive a 
Not Substantially Equivalent 
(NSE) Letter 
Document issued on: November 8, 2004 
For questions regarding this document contact Ginette Y. Michaud, MD at (301) 443-8913 ext. 
143 or ginette.michaud@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  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/reuse/guidance/1544.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 (1544) followed by the pound sign (#).  Follow the 
remaining voice prompts to complete your request.    Contains Nonbinding Recommendations 
Guidance for Industry and FDA Staff 
Frequently Asked Questions (FAQs) on the 
Status of Reprocessed Single Use Devices 
(SUDs) that receive a Not Substantially 
Equivalent (NSE) Letter 
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.  
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances 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 guidances means that something is suggested or 
recommended, but not required. 
1. What is a Not Substantially Equivalent letter and what does it mean if it
pertains to a reprocessed SUD?
In general, firms submit premarket information to FDA for the purpose of obtaining marketing 
approval or clearance of their devices prior to commercial distribution.  A premarket approval 
application (PMA) is usually required for entirely new types of devices, while a premarket 
notification submission (510(k)) may be submitted to demonstrate that a device is 
substantially equivalent to a legally marketed device (a predicate device) that did not 
require a PMA.   
If FDA agrees that a device for which a 510(k) has been submitted is substantially equivalent 
to a legally marketed device, FDA issues a Substantially Equivalent (SE) letter.  A Not 
Substantially Equivalent (NSE) letter is issued when FDA, based on the information 
submitted, determines that the device is not substantially equivalent to the already legally 
marketed device.  Like any other 510(k) applicant, a SUD reprocessor who submits a 510(k) 
and receives an NSE letter may not legally market the device subject to that 510(k) because it 
has not been cleared for commercial distribution by FDA. 
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Some firms who previously received SE letters for certain reprocessed SUDs were required, by 
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), to submit 
additional cleaning, sterility, and functionality validation data (supplemental data) for FDA to 
review in order to determine if these reprocessed devices could continue to be legally 
marketed.  If these firms either failed to submit the required supplemental data or FDA 
determined, based on the supplemental data submitted, that the reprocessed devices were not 
substantially equivalent to legally marketed predicate devices, the firms received NSE letters 
from FDA.  If a firm submitted supplemental data to FDA but later withdrew its 510(k)s as 
described in section 302(b) of MDUFMA, it received a letter acknowledging the withdrawal 
from FDA. 
Upon receipt of a NSE letter or a letter acknowledging withdrawal, the device subject to the 
letter may no longer be legally marketed.  The reprocessor may notify its customers that it can 
no longer reprocess that device at this time.  However, a reprocessor may submit a new 510(k) 
that includes the validation data required under MDUFMA and may be able to resume 
marketing if and when FDA determines that the information in the new 510(k) is adequate to 
establish substantial equivalence and issues a SE letter. 
2. Will FDA require reprocessors to recall a distributed device that is the
subject of a NSE letter or a letter acknowledging withdrawal?
Not necessarily.  FDA intends to contact each affected reprocessor to determine their 
plans for retrieval or withdrawal of distributed product.  In accordance with 21 CFR 
Part 7 and section 518(e) of the Federal Food, Drug, and Cosmetic Act (the Act), FDA 
will evaluate, on a case by case basis, whether the device that is the subject of the NSE 
or withdrawal letter should be recalled. 
3. Should a customer continue to use in-stock, reprocessed SUDs once the
reprocessor can no longer distribute as a result of a NSE letter or a letter
acknowledging withdrawal?
Upon receipt of a NSE letter or a letter acknowledging withdrawal, the device subject 
to the letter may no longer be legally marketed.  Customers may wish to contact the 
reprocessor to learn about any plans for retrieval or withdrawal of in-stock devices.  If 
the device warrants a recall, the recall strategy will specify the level to which the recall 
will extend, as described in 21 CFR Part 7 or section 518(e) of the Act.   
4. Is there an FDA site that lists information about which reprocessed SUDs
are no longer eligible for commercial distribution?
Reprocessors who received 510(k) clearances prior to the requirement under the law to 
submit supplemental data, have those 510(k)s posted on FDAs searchable 510(k) database 
at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.  Most SUD 
reprocessors who were required to submit supplemental data under MDUFMA, did submit.  
If FDA determined, based on a review of the supplemental data, that a device is Not 
Substantially Equivalent or if the SUD reprocessor requested withdrawal of the 510(k) and 
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supplemental data submission, the original 510(k) Substantial Equivalence determination 
was removed from the FDAs 510(k) database.  In addition, a list of the devices that can no 
longer be legally marketed is provided separately on FDAs reuse website at 
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
ReprocessingofReusableMedicalDevices/ucm20081513.htm.   
5. What other information can I learn from the FDAs website about the
status of reprocessed SUDs that were subject to supplemental data
requirements?
In addition to identifying reprocessed devices that can no longer be legally marketed, 
the site also lists those reprocessed devices for which FDA reviewed supplemental data 
submissions and determined that these devices remain substantially equivalent to 
legally marketed predicate devices.  MDUFMA did not require the submission of 
supplemental data for all reprocessed SUDs, however, so these lists will not provide a 
complete accounting of all reprocessed SUDs.  For additional information on the 
reprocessed devices for which supplemental data were required by MDUFMA, see List 
I and II published in the Federal Register on June 26, 2003 
(http://www.fda.gov/OHRMS/DOCKETS/98fr/03-16109.html, 68 FR 38071. 
6. If I have additional questions, who can I contact?
FDA recommends that you first contact the SUD reprocessor for information about the 
device in question.  You may also contact the 510(k) Staff within the Office of Device 
Evaluation, CDRH at (301) 594-1190 or the Office of Compliance, CDRH at (240) 
276-0100.
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