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The Food and Drug Administration (FDA) has issued the following answers to commonly asked questions regarding its regulatory initiative on reprocessing single-use medical devices:
Question: Are all health care facilities that reprocess single-use devices (SUDs) subject to the requirements?
Answer: At this time, FDA is limiting its focus to hospital and third-party reprocessors. In the future, FDA will examine whether other establishments that reprocess SUDs should be included.
Question: Does the SUD enforcement guidance apply to all reprocessed SUDs?
Answer: It does not apply to:
• permanently implantable pacemakers;
• "open-but-unused" single-use devices;
• hemodialyzers. The reuse of hemodialyzers is addressed in "Guidance for Hemodialyzer Reuse Labeling" (Oct. 6, 1995) at www.fda. gov/cdrh/ode/dilreuse.pdf.
Question: Which devices are known to be reprocessed?
Answer: Some examples of reprocessed SUDs are surgical saw blades, balloon angioplasty (PTCA) catheters, laparoscopy scissors, and endotracheal tubes.
For the complete list of SUDs known to be reprocessed, see Appendix A of the enforcement guidance at www.fda.gov/cdrh/comp/ guidance/1168.pdf.
Question: What are the regulatory requirements under the Food, Drug, and Cosmetic Act that hospitals must meet if they reprocess SUDs?
Answer: The regulatory requirements include:
• establishment of registration and device listing [21 Code of Federal Regulations (CFR) Part 807];
• good manufacturing practice (GMP) under the Quality System regulation (21 CFR 820);
• device labeling (21 CFR Part 801);
• submission of adverse events reports under the Medical Device Reporting (MDR) regulation (21 CFR 803);
• medical device tracking (21 CFR Part 821);
• corrections and removals (21 CFR Part 806);
• premarket requirements (21 CFR Parts 807 and 814).
Question: What is good manufacturing practice under the Quality System (QS) regulation?
Answer: Hospitals that reprocess SUDs must meet the QS regulation for medical devices (21 CFR Part 820).
The QS regulation requires a reprocessing hospital to have a quality assurance program or quality system that is appropriate for the specific type of device being reprocessed and that meets the requirements of the QS regulation.
FDA monitors compliance with the QS regulation during inspection of the facility. All registered hospitals that reprocess SUDs will be subject to periodic FDA inspection. The requirements under the QS regulation are intended to assure that continuing quality is incorporated into the devices during reprocessing, rather than by testing and removing defective devices to achieve quality.
Question: When must a hospital that reprocesses SUDs meet the regulatory requirements?
Answer: For hospital reprocessors, FDA is allowing a one-year phase-in period for active enforcement of the nonpremarket requirements. FDA intends to enforce premarket submission requirements by:
• Feb. 14, 2001, for class III devices;
• Aug. 14, 2001, for nonexempt class II devices;
• Feb. 14, 2002, for nonexempt class I devices.
Question: What are class I, II, and III devices?
Answer: In general, the CFR designates a three-tiered device classification system.
Class III devices are generally considered to pose the greatest potential risk to the health of the public and require the most regulation, while class I devices pose the lowest potential risk and require the least regulation.
A device’s classification is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm.
Question: How do I know which premarket regulatory requirements apply to my reprocessed device?
Answer: The device classification of a reprocessed SUD determines if, when, and what type of premarket submission is required.
• If your reprocessed SUD is classified as class I or class II and is exempt, no premarket submission is required.
• If your reprocessed SUD is classified as class I or class II and is not exempt, a premarket notification, known as a 510(k), is required.
• If your reprocessed SUD is classified as class III, generally a premarket approval application, known as a PMA, is required.
Question: How do I register and list reprocessed SUDs?
Answer: A hospital that reprocesses SUDs must register with FDA and list every type of reprocessed device.
For additional information, see "CDRH Guidance for Industry: Instructions for Completion of Medical Device Registration and Listing Forms FDA-2891, 2891a, and 2892" at www.fda.gov/cdrh/dsma/rlman.html or the PDF version at www.fda.gov/cdrh/ rlmanul.pdf.
Question: What is required for device labeling?
Answer: FDA has general labeling requirements regarding the name and place of manufacture and inclusion of adequate directions for use. See "Labeling Regulatory Requirements for Medical Devices" at www.fda.gov/cdrh/dsma/ 470.pdf.
Question: How do I report an adverse event with an SUD?
Answer: Hospitals that reprocess SUDs are subject to the manufacturer reporting requirements as well as the user-facility reporting requirements (21 CFR 803 Subpart E).
In addition, hospitals must adhere to the user facility reporting requirements for all other medical devices that they use. See guidance documents on MDR at www.fda.gov/cdrh/mdr.html.