对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-...
Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance Topics Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premar...
对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov/medical-devices/device-advice-compr...
IV. Q-申请计划在本指南中,“Q-申请(Q-Submission)”或“Q-申请(Q-Sub)”指的是用于跟踪上述互动收集的系统。对于申请人来说,这是与FDA分享信息并接收IDE、IND、上市提交或CW以外意见的重要机会。在上市前提交过程中,Q-申请可作为有用的工具,鼓励FDA审查员在审查Q-申请的同时与提交人进行互动工作27,以便...
Types of Submissions That Must Adhere to the Electronic Submission Requirement Described in This Guidance 3 B. Timetable for Implementation of Electronic Submission Requirements 5 C. Types of Submissions Exempted From the eCTD Requirement Described in This Guidance6 D. Certain Positron Emission ...
The FDA has taken a major fi rst step towards providing electronic submission templatesfor manufacturers of medical devices. Newly issued draft guidance outlines proposedchanges that will impact industry members that make De Novo electronic submissionsto the Center for Devices and Radiological Health (...
打开可以发现更细节信息。比如:提交方式 Submission Type(510K),GMP豁免(No),第三方审核Third Party Review,以及可供选择的第三方Accredited Persons。 既然发现是510K,进而到510K数据库中搜索同类产品。在Product Code栏中输入HKP。 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm ...
· if the sterilization method has been evaluated through clearance of a 510(k) or approval of a PMA or HDE for a device using that method, the submission number where the method was previously evaluated or the iden...
This guidance is intended for devices that include clinical information in support of a marketing submission, whether a premarket notification (510(k)), premarket approval (PMA) application, 185evaluation of Automatic Class III Designation (de novo request), or humanitarian device exemption (HDE) app...
The FDA is partially supported by industry user fees, but the FDA charges much smaller user fees to review medical devices than it charges to review prescription drugs, even for the largest companies. In 2010, the FDA charged a standard fee of $4007 for a 510(k) submission (and only ...