For questions regarding devices regulated by the Center for Devices and Radiological Health, 
contact the Infection Control Devices Branch (INCB) at (301) 796-5580. Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of Human 
Resources and Management Services, 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/ohip/guidance/1427.pdf.  You may also send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
301-847-8149 to receive a hard copy.P(cid:13) lease use the document number (1427) to identify the
guidance you are requesting.(cid:10) (cid:13) 
 
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry, FDA Staff, Third-
Party and Hospital Reprocessors 
 
Frequently-Asked-Questions about  
the Reprocessing and Reuse of  
Single-Use Devices by Third-Party and 
Hospital Reprocessors; Three Additional 
Questions 
 
 
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.  
 
Introduction 
 
This document is intended to provide guidance. It represents the Agency'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 the Food and Drug Administration (FDA) or the public. An 
alternative approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations. 
 
Background 
 
On August 14, 2000, the Food and Drug Administration released a document entitled 
"Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" 
to provide guidance to third-party and hospitals reprocessors about their responsibilities as 
manufacturers engaged in reprocessing devices labeled for single use under the Federal Food, 
Drug, and Cosmetic Act (the Act), as amended by the Safe Medical Devices Act of 1990, the  Contains Nonbinding Recommendations 
 
Medical Device Amendments of 1992, and the Food and Drug Modernization Act of 1997.  
Third-party and hospital reprocessors of single- use devices (SUDs) are subject to all the 
regulatory requirements currently applicable to original equipment manufacturers, including 
premarket submission requirements (Section 513 and 515 of the Act; 21 Code of Federal 
Regulations Parts 807 and 814). 
 
Since its release on August 14, 2000, the agency has received numerous questions about the 
enforcement priorities guidance. The following questions and answers are meant as 
clarification of the original document. This guidance will be updated as the need arises. 
 
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.  
 
 
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/resolvingdisputes/ombudsman.html.  
 
 
 
Questions related to 
REGISTRATION AND DEVICE LISTING 
 
 
Question: My establishment is registered as a manufacturer of medical devices, some of 
which are labeled for single use. We also reprocess for reuse some of the single-use devices 
that we manufacture. Do we have to add the establishment operation type of "Reprocessor of 
Single-Use Devices" to our existing registration information? 
 
 
Answer: Yes, your establishment needs to be registered for all of the operations that are 
being performed at the same location. 
 
  Contains Nonbinding Recommendations 
 
 
Question: My establishment is registered as a manufacturer of medical devices, some of 
which are labeled for single use. We also reprocess for reuse some of the single-use devices 
that we manufacture. Do we have to update our existing device listing information? 
 
 
Answer: Yes, your establishment needs to have all of the operations that are being 
performed on a particular device listed with FDA. 
 
 
 
Question related to 
HOSPITAL AND THIRD PARTY REPROCESSORS 
 
 
Question:  Must all hospitals that use reprocessed devices intended for single use comply 
with the FDA requirements applicable to medical device manufacturers? 
 
 
Answer:  No.  Only those hospitals that actually reprocess medical devices labeled for single 
use must comply with FDAs medical device requirements applicable to manufacturers.  
FDAs regulatory requirements do not apply to hospitals that use a third party reprocessor to 
reprocess SUDs for reuse.