美国FDA 指导原则 投放市场前通知(510(K))提交的一般外科电外科设备工业和食品药品管理局工作人员指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff Document issued on March 9, 2020. Document originally issued on August 15, 2016. The draft of this document was issued on March 24, 2014. For questions about this document, contact OHT4: Office of Surgical and Infection Control Devices/ DHT4A: Division of General Surgery Devices, 301-796-6970. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health 1 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-0217. 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 include the document number 19029 and complete title of the guidance in the request. 2 Contains Nonbinding Recommendations Table of Contents I. Introd