Standard Terminology for Combination Products (Drug/Medical Device/Biologic Combinations)

Importancia y uso:

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.

Subcomité:

E55.91

Volúmen:

14.01

Palabras clave:

borderline product; combination product; combined use; co-packaged product; cross-labeled product; platform; primary mode of action; principal mode of action; referenced product; single-entity product; single-integral product; software as a medical device ;