美国FDA 指导原则 软性(亲水性)日常佩戴隐形眼镜.工业和食品药品监督管理局工作人员安全和基于性能的路径指南的性能标准 英文原版.pdfVIP

Contains Nonbinding Recommendations Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway ______________________________________________________________________________ Guidance for Industry and Food and Drug Administration Staff Document issued on March 28, 2023. The draft of this documents was issued on March 4, 2020. For questions about this document, contact the DHT1A: Division of Ophthalmic Devices at 301- 796-5620. 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 Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2019-D-4843. 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 GUand complete title of the guidance in the request. 2 Contains Nonbinding Recommendations Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performa