This document is to be used by manufacturers of ultrasonic therapy devices in the preparation of product reports, as required by the Code of Federal Regulations, Title 21 (21 CFR), parts 1002.10 and 1002.11. In sections 1.0 through 3.4 of this guide, the requested information should be given in the spaces provided. These pages should then be removed from the guide and combined with the information requested in sections 3.5 through 5.4 to form the completed report. Please be sure that all information supplied as sections 3.5 through 5.4 is clearly identified. Part 1002.7(b) of 21 CFR requires that reports be filed using this guide, unless otherwise specified. Maintain a blank copy of this guide for future use, and maintain a copy of each completed report for your records.
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.