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GUIDANCE DOCUMENT

Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry October 2019

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Not for implementation.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 The draft guidance for industry Drug Master Files (October 2019) (hereinafter DMF guidance) and the DMF web page identify the types of DMFs that may be submitted.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.

 
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