治疗及改善真菌感染的指甲外表的医疗器械及临床试验设计英文版.pdf

Contains Nonbinding Recommendations Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails Guidance for Industry and Food and Drug Administration Staff Document issued on: March 7, 2016. The draft of this document was issued on January 27, 2015. For questions about this document, contact General Surgery Devices Branch 1, 301-796-6970 and Mr. Neil Ogden, 301-796-6397, neil.ogden@. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Surgical Devices Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to . Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2014-D-1849. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to CDRH- Guidance@ to receive a copy of the guidance. Please use the document number 1400009 to identify the guidance you are requesting. Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 3 III. TE