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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices |
| Internet: | http://www.fda.gov/cdrh/ode/guidance/1216.pdf |
| Origin/Publisher: | FDA |
| Content: | On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amended the Federal Food, Drug, and Cosmetic Act (the Act) by adding new section 510(o), which provided new regulatory requirements for reprocessed single-use devices (SUDs). According to this new provision, in order to ensure that reprocessed SUDs are substantially equivalent to predicate devices, 510(k)s for certain reprocessed SUDs identified by FDA must include validation data. These required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification. |
| Status: | Guidance |
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