# Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data
> **Food and Drug Administration** · Direct final rule. · Published 2006-09-25 · Effective 2007-02-07 · 71 FR 55729
## Document
- **Document number:** 06-8166
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 71 FR 55729
- **CFR reference:** 21 CFR 807
- **Publication date:** 2006-09-25
- **Effective date:** 2007-02-07
- **HHS docket:** Docket No. 2006N-0335
## Abstract

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2006/09/25/06-8166/medical-devices-reprocessed-single-use-devices-requirement-for-submission-of-validation-data)
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