On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices.  The guidance describes when a Type V drug master file (DMF) can be used to provide information to the Center for Drug Evaluation and Research (CDER) about a device constituent part with electronics and/or software that is planned for use as a platform across multiple CDER-led combination products.

The types of functions these device constituent parts could perform include:

• facilitating drug delivery in a manner that may include patient input or analysis (e.g., electromechanically driven pen injector),
• providing information that is used to make a decision regarding treatment, therapy, or drug delivery,
• interfacing with other devices or systems to provide information (e.g., physiological parameters) to the user or health care provider, and
• controlling or driving features of the user interface.

FDA expects that these Type V DMFs will enhance efficiency and consistency in the review process for CDER-led combination products.  As the draft guidance notes, “For such combination products, a Type V DMF can be an efficient mechanism to provide information regarding the device constituent part when the same information is applicable to several CDER applications.”  In particular, the draft guidance highlights that once FDA has reviewed the device information contained in a Type V DMF for a CDER application, the agency may rely on the previously completed review for future applications referencing the same information.  The guidance also clarifies that electronics and software that do not meet the statutory definition of a medical device (e.g., software that is only intended to display or transfer patient data or other medical information) would not be expected to be included in a DMF.

The draft guidance makes recommendations on the content that should be included in Type V DMF submissions, amendments, and annual reports, and it outlines the administrative procedure for DMF submissions and review.  As with other Type V DMFs, a prospective DMF holder must send FDA’s DMF staff a letter of intent prior to submitting the DMF.  The letter of intent should include:

• the name, title, address, and contact information for the prospective DMF holder and a contact for FDA correspondence,
• the name of the CDER-led combination product and the name, title, address, and contact information for the combination product applicant,
• an identification and brief description of the device constituent part that is the subject of the DMF,
• a brief description of how the device constituent part in the DMF is used or how it functions in the combination product, if known, and
• the purpose and rationale for submitting the Type V DMF, which should explain why the information is not being submitted in an IND, NDA, ANDA, or BLA or amendments and supplements to these applications (e.g., intent to use the device constituent part with more than one drug product, or submission of confidential or proprietary information that is not available to the applicant).

Recognizing that these types of device constituent parts may incorporate technology that is advancing rapidly, the draft guidance anticipates that they may be modified frequently.  Upon such modifications, the DMF holder must report the change in an amendment to the DMF and notify each person authorized to reference the information.  Any applicant whose application incorporates the DMF by reference will in turn be responsible for determining whether a submission to the approved or pending application is necessary.

This new draft guidance complements other recent agency actions to support the development and use of digital health tools with drug products, including FDA’s November 2018 proposal for the regulation of prescription drug-use-related software output, which we discussed here.

Comments on the draft guidance must be submitted by December 27.