FDA 发布 CDER 主导、含电子或软件器械组件组合产品的 Type V DMF 指南草案
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software
FDA 发布指南草案《Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software》，文件编号 FDA-2019-D-4258，由 CDER 发布，属不用于实施的非约束性建议。
材料说明 Type V DMF 用于提交 DMF II–IV 未涵盖的参考信息，并标明草案状态与评论途径，便于读者核对适用范围。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-4258
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The draft guidance for industry Drug Master Files (October 2019) (hereinafter DMF guidance) and the DMF web page identify the types of DMFs that may be submitted. A Type V DMF is intended for the submission of FDA-accepted reference information and supporting data that are not covered by DMF Types II–IV.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-4258.
来源：FDA Pharmaceutical Quality Documents · fda.gov