Safe Reprocessed Medical Devices Act of 2002
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Directs the Secretary of Health and Human Services to review, according to specified criteria, a Class I or Class II reprocessed device whose producer is exempt from having to report preceding the device's introduction into state commerce. Requires the Secretary to publish in the Federal Register a list of such devices that are no longer exempt.
Declares that the termination of an exemption from reporting requirements for a reprocessed device shall not terminate the exemption for the original device.
Directs the Secretary to perform specified duties with respect to those reprocessed single-use devices that require reports, including to require validation data. Prohibits the Secretary from determining that such a device is misbranded or adulterated or from taking action against the device for a failure to provide certain required information unless one of specified conditions are met, including that the device is not substantially equivalent to a predicate device. Prohibits marketing the device if it is not substantially equivalent.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate Formatted Text PDF
Cite this page
U.S. Congress. (2026). S. 3130: Safe Reprocessed Medical Devices Act of 2002. 107th Congress. Open America. https://openamerica.io/bill/107-S-3130/
"S. 3130: Safe Reprocessed Medical Devices Act of 2002." 107th Congress, 2026, Open America, https://openamerica.io/bill/107-S-3130/.
S. 3130, 107th Cong. (2026), https://openamerica.io/bill/107-S-3130/.
[S. 3130: Safe Reprocessed Medical Devices Act of 2002](https://openamerica.io/bill/107-S-3130/)