Publications and Presentations

Published Articles on Combination Products by Michael Gross, Ph.D., RAC

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FDA Issues Final Guidance on Medical Device Human Factors Studies

US FDA Issues Guidance on Human Factors Studies for Combination Products

Quality and Systems Usability Requirements for Drug Delivery Systems

US FDA Issues Final Rule for Combination Product Quality Systems

FDA Issues Its Final Rule for Combination Product Quality Systems

Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

Reporting Manufacturing and Design Changes to Combination Product Marketing Applications

Postmarket Safety Reports for Combination Products

Combination Product Quality Systems

Combination Product Labeling

Structuring Combination Product Marketing Applications

Combination Product Terminology

FDA Issues Draft Guidance on Injectors

The Combination Product Problem

Complying with FDA Quality Regulations for Development and Manufacture of Prefilled Drug Delivery Devices


White Papers

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Analysis: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff

Analysis of Draft Guidance- Current Good Manufacturing Practice Requirements for Combination Products

Analysis of FDA Warning Letter Issued to Amgen for Non-compliance with Combination Product CGMP

Analysis of Guidance – Design Considerations for Devices Intended for Home Use


Recent Presentations

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Arden House Conference
April 3, 2017 Rockville, MD