FDA发布终版医疗器械生产地址变更指南日期：2018-12 / 人气：168
终稿指南文件还在草案基础上，对FDA的设备和放射卫生中心(CDRH)及生物制品评价和研究中心(CBER)提供了第四种评判标准，用来判定是否须按照21 CFR Part 820的要求，对“生产变更补充申请”的新生产地址实施检查。FDA表示：“该指南将帮助企业管理生产地址、任何工艺流程、方法、程序、资质和验证相关变更的时间框架。”
FDA Finalizes Guidance on Changes to Device Manufacturing Sites
The US Food and Drug Administration (FDA) issued final guidance intended to help industry determine applicable requirements for a change to a medical device manufacturing site.
The 19-page guidance is largely similar to the draft version released in 2015. It includes a few new clarifications around whether a change to a manufacturing site is likely to require a premarket approval application (PMA) supplement or is eligible for a 30-day notice. Certain policies were added to the draft section on whether a preapproval inspection may be needed.
“An applicant should submit a 180-day PMA supplement for using a different site…that affects the device’s safety or effectiveness,” FDA added to the draft section on site change supplements versus 30-day notices. “Manufacturing process changes that are not directly associated with the facility move should be submitted separately [via a 30-day notice or a PMA annual report] and are not considered part of the manufacturing site change supplement.”
The final guidance also added a fourth criterion to those in the draft under the approach used by FDA’s Center for Devices and Radiological Health (CDRH) and its Center for Biologics Evaluation and Research (CBER) to determine whether to conduct an inspection of a new manufacturing site associated with a site change supplement to evaluate implementation of quality system requirements under 21 CFR Part 820. “As a result, this guidance should help firms manage the timeframes associated with implementing the changes in the manufacturing site and any processes, methods, procedures, qualifications and validations,” the agency said.
CDRH and CBER will generally reach these decisions on inspections partly based on “a review of relevant recalls and adverse events, associated with manufacturing processes,” the new criterion states. The other three relate to dates of last site inspections and their classifications, relevance of the last quality system inspection, as well as “the risk to the safety or effectiveness of the device associated with the manufacturing activities performed at the new site.”
The finalized version of the guidance also clarified “manufacturers may contact the appropriate office to discuss whether a pre-approval inspection may be required; the pre-submission process may be utilized for these interactions, if appropriate.” The polices are limited to firms with approved PMAs, product development protocols or humanitarian device exemptions.