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JAMA. 2001;286:1569.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has begun to require compliance with specifications designed to ensure that reprocessed single-use medical devices are as safe and effective as new ones. In the first stage of the program, the agency is requiring that the highest-risk (class III) devices–such as PTCA catheters—that are reprocessed by hospitals and firms for reuse receive FDA premarket approval based on data showing safety and effectiveness. The only exceptions are cardiac ablation catheters reprocessed by four firms that have received an extension to complete clinical studies. Any other unapproved products may be reused only as investigational devices with the approval of the institutional review board and the patient's informed consent.

Reprocessors of moderate risk (class II) devices, such as cardiac mapping catheters, must now submit to the FDA notifications showing that the reprocessed products are substantially equivalent to new ones. The agency will evaluate the evidence and start requiring premarket clearance for . . . [Full Text of this Article]

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