This guidance document describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act. In addition, it provides guidance to industry and FDA staff on submission and review procedures for validation data in 510(k)s for reprocessed SUDs. This guidance supersedes the guidance of the same title, issued June 1, 2004. In this revised version, we clarify the use of FDA-recognized standards and the applicability of the Special 510(k) Program to 510(k)s submitted with validation data. We also clarify the obligations of an OEM who reprocesses SUDs. Lastly, the 2004 document addressed initial MDUFMA implementation issues; many of which are no longer relevant and have been removed. If, in the future, additional device types are added to the list of reprocessed SUDs requiring validation data, a Supplemental Validation Submission (SVS) will be required for those devices and this guidance will provide information on the type of validation data that should be submitted.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.