New CDER Guidance on Platform Software

This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has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Download the draft guidance: Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance-2019

Need help with a combination product submission?  With Type V DMF strategy for a “software ecosystem” master file?  Contact us to discuss.

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Upcoming SoftwareCPR Training Courses:

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here:–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


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