Work Item
ASTM WK72293

New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)

1. Scope

This Standard defines and gives examples of Combination Product presentations. This could include presentations such as combinations of Drug and Device and/or Biologics. The standard will define types of combination products at a high level.


Combination Product; Combo Product; Mode of Action; PMOA; Biologic Combinations


Currently, there are a variety of terminologies and definitions within different jurisdictions. This Standard Guide will serve as the global reference for Combination Products and related topics.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E55.91

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 03-16-2020

Technical Contact: Manfred Maeder

Item: 001

Ballot: E55.03 (22-01)

Status: Will Reballot Item

Item: 004

Ballot: E55 (22-05)

Status: Will Reballot Item

Item: 002

Ballot: E55 (23-02)

Status: Will Reballot Item