SCG

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

产品代码

SCG

器械名称

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

管理类别

第 N 类（Not Classified）

FDA 专业组

Unknown

上市路径

Enforcement Discretion

FDA 分类定义

When a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting CLIA’s regulatory requirements to perform high complexity testing modifies another manufacturer’s 510(k) cleared or De Novo authorized test, and in compliance as described in section V.C.3 of the preamble to the LDT Final Rule, in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification as described in sections V.C.4 and V.C.5 of the preamble to the LDT Final Rule (89 FR 37286).

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。