Food and Drug Administration
U.S. Department of Health and Human Services
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T00-34 Sharon Snider: 301-827-6242
August 2, 2000
Consumer Inquiries: 888-INFO-FDA
FDA today issued final guidance on the practice of reusing medical devices intended to be used only once.
The guidance is designed to protect the public health by assuring that the practice of reprocessing and reusing "single-use" medical devices is based on good science, while ensuring that the regulatory requirements are equitable to all parties.
The reprocessing of medical devices labeled, or intended, for only one use has grown steadily in recent years, as has the complexity of the devices being reprocessed. This trend has intensified concern about patient safety, informed consent, the ethics of this practice and the equitable regulation of original equipment manufacturers and reprocessing firms.
Under the final guidance, FDA will regulate third-party processors and hospitals that engage in reprocessing of single-use devices the same way the agency now regulates original equipment manufacturers. This includes: pre-market notification and approval requirements, registration and listing of firms, submission of adverse event reports, manufacturing requirements, labeling requirements, medical device tracking and correcting or removing from the market unsafe medical devices.
FDA's enforcement priorities for the pre-market submission requirements will be based on the existing medical device classification system: class I for low risk devices, class II for moderate risk devices, or class III for high risk devices. FDA intends to actively enforce the pre-market submission requirements for third party and hospital reprocessors in six months for class III devices, in 12 months for class II non-exempt devices, and in 18 months for class I non-exempt devices. At a later date, FDA will examine on a case-by-case basis the need to revoke exemptions from pre-market requirements for class I and II exempt products based on the risk that may exist due to reprocessing.
FDA will continue as previously to enforce other existing requirements for third party reprocessors including: registration, listing, medical device reporting, tracking, corrections and removals, manufacturing and labeling. However, FDA intends to phase in enforcement of existing non pre-market requirements for hospital reprocessors within one year of the issuance of the guidance. The agency will use this time to educate hospitals about their regulatory obligations.
In issuing its final guidance, FDA considered more than 150 comments received on its proposed strategy which was published November 3, 1999, discussions at an FDA teleconference November 14, a public meeting December 14, and two draft guidance documents published Feb. 11, 2000.
The guidance, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals," is available on FDA's web site at www.fda.gov/cdrh/comp/guidance/1168.pdf.
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Hypertext uploaded by clb 2000-AUG-02.