Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices" (validation data guidance). The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), added a section to the act to establish new regulatory requirements for reprocessed single-use devices (SUDs). MDUFMA was signed into law on October 26, 2002. One requirement of the new provision is the submission of validation data for certain class I and II reprocessed SUDs. This guidance document is intended to assist manufacturers of reprocessed SUDs in understanding and complying with this new MDUFMA requirement. The new section of MDUFMA establishes requirements applicable only to reprocessed SUDs.