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Last Updated: May 27, 2026
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ASTM E3357-26
Standard Terminology for Combination Products (Drug/Medical Device/Biologic Combinations)
Standard Terminology for Combination Products (Drug/Medical Device/Biologic Combinations)
E3357-26
ASTM|E3357-26|en-US
Standard Terminology for Combination Products (Drug/Medical Device/Biologic Combinations)
Standard
E3357 Standard Terminology for Combination Products (Drug/Medical Device/Biologic Combinations)>
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BOS Vol. 14.01 Committee E55
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ASTM International
Significance and Use
3.1 Currently, there are a variety of terminologies and interpretations applied across jurisdictions globally with respect to combined use of medical products in which two or more differently regulated medical products are to be used together or are being studied for use together to achieve an intended use, indication, or effect.
3.2 Combined use medical products inherently raise distinct/additional questions that need to be considered and may lead to a range of risk management/regulatory approaches based on where the product/use sits along a continuum of risk. There is a need to consider more than one medical product in risk analysis and control strategy, and the requirements should be based on the scientific and technological considerations raised by the intended combined use of the medical products.
Scope
1.1 Some countries/regions have adopted the classification “combination product” as a regulatory construct for combined use medical products, while others apply different terminology and constructs. Given the challenges with terminology and concepts, in this standard, terminology, major challenges, and key considerations associated with combined use medical products are identified, including those referred to as “combination products.”
1.2 In this terminology standard, the terms “combined use” and “combination product” as well as categories of combination products and other related terms are defined.
1.3 The terminology provided within this standard reflects common themes and definitions across jurisdictions. Examples and categorization of combination products will be provided. The aim of this terminology standard is to serve as a global reference for combination products and related topics.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.