User fee negotiations in US offer hope for improvements to interactive review for medical device submissions

Kristin M Zielinski

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User fee negotiations in US offer hope for improvements to interactive review for medical device submissions

机译：美国的使用费谈判为改善医疗设备提交的交互式审核提供了希望

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The US Food and Drug Administration's interactive review programme for medical device marketing applications is a critical process aimed at ensuring that companies are able to understand and meet the agency's expectations and bring their products to market in a timely fashion. The programme was formalised in the Medical Device User Fee Amendments of 2007 (MDUFA) as part of the reauthorisation of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, following successful negotiations by the medtech industry. Its creation was intended to improve interactions between FDA reviewers and companies during a product review, both to resolve minor issues informally and to alert the applicant to major issues identified by the FDA in advance of the agency issuing a formal letter

机译：美国食品和药物管理局针对医疗器械营销应用程序的交互式审核程序是一个关键过程，旨在确保公司能够理解并满足该机构的期望，并及时将其产品推向市场。在经过医疗技术行业的成功谈判之后，该计划在2007年的《医疗设备用户费用修正案》（MDUFA）中得到了正式批准，这是对2002年《医疗设备用户费用和现代化法案》（MDUFMA）进行重新授权的一部分。它的创建旨在改善产品审查过程中FDA审查人员与公司之间的互动，既可以非正式地解决小问题，也可以在机构发出正式信函之前提醒申请人注意FDA确定的主要问题。

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《Regulatory Affairs Journal- Devices》 |2011年第julaauga期|共4页
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Kristin M Zielinski;
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1. User fee negotiations in US offer hope for improvements to interactive review for medical device submissions [J] . Kristin M Zielinski Regulatory Affairs Journal- Devices . 2011,第JulaAuga期

机译：美国的使用费谈判为改善医疗设备提交的交互式审核提供了希望
2. Law doubles user fees on medical device makers in US [J] . Plastics news Group Plastics news . 2012,第7期

机译：法律使美国医疗器械制造商的使用费增加了一倍
3. Congress Passes FDA Medical Device User Fee Bill - Clinical Lab Products [J] . Clinical Lab Products . 2012,第2012期

机译：国会通过FDA医疗设备用户费用法案-临床实验室产品
4. A REVIEW OF COMMERCIAL-OFF-THE-SHELF PERSONAL NAVIGATION DEVICES FOR MILEAGE BASED USER FEES [C] . Robert Zimmer, Matthew Burns, Bennett Pierce, ITS world congress on intelligent transport systems . 2011

机译：基于里程数的用户费用的商用现成个人导航设备的回顾
5. A Dynamic Behavioral Biometric Approach to Authenticate Users Employing Their Fingers to Interact with Touchscreen Devices. [D] . Ponce, Arturo. 2015

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6. Gordonia araii Infection Associated with an Orthopedic Device and Review of the Literature on Medical Device-Associated Gordonia Infections [O] . Deanna P. Jannat-Khah, Eric S. Halsey, Brent A. Lasker, 2009

机译：骨科器械相关的阿拉伯戈登菌感染及与医疗器械相关的戈登菌感染文献综述
7. Acreditation Certificate Acreditation No. 21/E/KPT/2018 Article Tools Print this article Indexing metadata How to cite item Email this article Email the author About The Authors Ainun Ramadhani Tri Wahyuni ORCID iD https://orcid.org/0000-0002-4071-3406 Fisheries and Marine Science Faculty, Brawijaya University Indonesia Endang Yuli Herawati Fisheries and Marine Science Faculty, Brawijaya University Indonesia Andi Kurniawan ORCID iD Fisheries and Marine Science Faculty, Brawijaya University Indonesia Abd. Aziz Amin ORCID iD Coastal and Marine Research Center, University of Brawijaya, Indonesia Indonesia About RJLS Aim and Scope Editorial Board Reviewer Acknowledgement Publication Ethics Visitor Statistic Information for Author Author Guidelines (online version) Online Submission Guideline Online Registration Author Fees Download Template User You are logged in as... riris_rjlsub My Profile Log Out Tools Mendeley User Guide Insert Citation using Mendeley Journal Index Visitor Statistic Notifications View (141 new) Manage Journal Content Search Search Scope Browse By Issue By Author By Title Information For Readers For Authors For Librarians Keywords Antioxidant Bali Strait Biogeography CODIS 13 Calamaria DPPH Dyslipidemia Eucheuma cottonii ICP11 Litopenaeus vannamei Macrobrachium rosenbergii Morphology Pandanus Physalis minima RFLP Sardinella lemuru Sperm WSSV birth weight fermentation rats Isolation, and Identification of Diesel Oil Degrading Bacteria in Water Contamination Site and Preliminary analysis with Potential Bacterial Gordonia terrae [O] . Ainun Ramadhani Tri Wahyuni, Endang Yuli Herawati, Andi Kurniawan, 2019

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8. Guidance for Industry and FDA Staff. Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements [R] . 2008

机译：工业和FDa工作人员指南。医疗器械提交的互动审查：510（k）s，原始pma，pma补充，原始BLa和BLa补充

User fee negotiations in US offer hope for improvements to interactive review for medical device submissions

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