近日，FDA更新了其政策和程序手册（MAPP）——5014.1 Rev. 1《CDER基于风险的选址模型》。该文件详细说明了FDA将如何根据选址模型（SSM）优先考虑受检查单位。本次更新增加了一个风险考虑因素：公司所在国家或地区的合规历史，包括该国家或地区出口的（受此类法规约束的）产品相关的违规历史。
原文如下：
The SSM will use risk factors consistent with section 510(h)(4) of the FD&C Act. This provision identifies specific risk factors and allows FDA to determine additional ones, as follows:
SSM（选址模型）将使用符合FD&C法案第510（h）（4）条的风险因素。该条款确定了特定的风险因素，并允许FDA确定其他风险因素，如下：
a) The compliance history of the establishment.
公司的合规历史。
b) The record, history, and nature of recalls linked to the establishment.
与该公司相关的召回记录、历史和性质。
c) The inherent risk of the drug or device manufactured, prepared, propagated, compounded, or processed at the establishment.
该公司药物或器械的固有风险。
d) The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 704 of this title [the FD&C Act (21 U.S.C. 374)] within the last 4 years.
该公司的检查频率和历史，包括在过去4年内是否根据FD&C法案（21 U.S.C. 374）第704条对该公司进行了检查。
e) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 809 of this title [the FD&C Act (21 U.S.C. 384e)].
该公司是否已接受外国政府或根据FD&C法案（21 U.S.C. 384e）第809条认可的外国政府机构的检查。
f) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this Act [the FD&C Act], including the history of violations related to products exported from such country or region that are subject to such regulation.
该公司所在国家或地区的合规历史，包括该国家或地区出口的（受此类法规约束的）产品相关的违规历史。
g) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.4
为分配检查资源而必要和适当的任何其他标准。
另一项更新为：药品质量办公室（OPQ）内一个部门名称由“监督办公室”变更为“质量监督办公室（OQS）”。
