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Reprocessed Single-Use Devices – New regulations” as part of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250

The FDA announced new requirements for the reprocessing of Single-Use medical devices in the MDUFMA and defined these requirements in the Fed. Reg. Announcement, December 20, 2002. - (http://www.fda.gov/cdrh/mdufma/faqs.html#reprocessed)

Under the new law, reprocessors of some exempt devices will no longer be exempt from the 510(k) submission requirements but rather will need to submit 510(k)s that include validation data. This is a major change from the original act.

The new law will also require that “validation data will also be required for many reprocessors of single-use devices that are currently the subject of cleared 510(k)s. Finally, reprocessors of class III devices will need to submit a premarket report (a new type of premarket application).”

One other major change is in the required labeling.

To answer the following question, “What labeling changes are required for reprocessed single-use devices and when must the new labeling be used?”

Any reprocessed single-use device (i.e., devices exempt from 510(k) requirements, subject to 510(k) requirements, or subject to a premarket report) introduced into interstate commerce after January 25, 2004 must “prominently and conspicuously” bear the statement:

Reprocessed device for single use. Reprocessed by [name of manufacturer that reprocessed the device] .

This provision will make it easier for patients and health care professionals to know when they are using a reprocessed device.

If any questions please email mdi at MDUFMA@mdiconsultants.com or contact us directly at 516-482-9001.

U.S. AGENT SECTION

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