This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., CDER-led combination product) and the device portion has electronics and/or software that is planned to be used as a platform, that is, may be used in multiple CDER-led combination products. The guidance also describes the administrative process and outlines the recommended content for these Type V DMF submissions and amendments.
Alternatively, applicants may also choose to incorporate by reference device constituent part information available in other submission types, such as a premarket notification submission (510(k)); premarket approval application (PMA); request for classification submitted under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (De Novo request); or device master file (MAF).
The guidance gives these examples as possible applications:
- Facilitate drug delivery in a manner that may include patient input or analysis (e.g., an electro-mechanically driven pen injector with software that allows input of patient or dosing information or that analyzes dosing or device use information).
- Provide information that is used in making a decision regarding treatment, therapy, or drug delivery.
- Interface with other devices or systems to provide patient use or other information to the user or health care provider (e.g., physiological parameters).
- Control or drive the features of the user interface.
The guidance describes the necessary information for a Type V DMF submission and, as one would expect, “software information and documentation” is an expectation in the Technical Information section. We would expect similar documentation as specified by CDRH in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
Download the draft guidance: Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance-2019
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