Document issued on: July 16, 2003
This document supersedes Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third Party and Hospital Reprocessors; Two Additional Questions; Final Guidance
for Industry and FDA Staff, December 11, 2002
For questions regarding devices regulated by the Center for Devices and Radiological Health, contact the Infection Control Devices Branch (INCB) at (301) 796-5580
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Outreach and Public Participation Branch
Division of Device User Programs and Systems Analysis
Office of Health and Industry Programs
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 are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number (1427) to identify theguidance you are requesting.
Contains Nonbinding Recommendations
Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors
the Reprocessing and Reuse of
Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions
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.
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 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.
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.
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 FDA’s medical device requirements applicable to manufacturers. FDA’s regulatory requirements do not apply to hospitals that use a third party reprocessor to reprocess SUDs for reuse.