Guidance for Industry and Food and Drug Administation Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions for Reprocessed Single-Use Medical Devices; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of the revised 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). This guidance document is being revised to include the procedures and timeframes that the agency intends to follow in its review of the validation data required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), for certain reprocessed single-use devices (SUDs), to include updated references to relevant Federal Register notices, and to include a section addressing the Paperwork Reduction Act of 1995 (the PRA). This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).