Regulatory Terms Starting With I

ICH M7 (ICH M7)

The ICH guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

IEC 62304 (IEC 62304)

The international standard defining software lifecycle processes for medical device software.

In Vitro Diagnostic (IVD)

A medical device used to perform tests on samples taken from the human body to detect diseases, conditions, or infections.

IND-Enabling Studies (IND-Enabling)

The nonclinical studies a sponsor conducts to support the safety and feasibility of initiating human clinical trials under an IND.

Informed Consent (ICF)

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

Institutional Review Board (IRB)

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

International Council for Harmonisation (ICH)

A global organization that develops harmonized pharmaceutical guidelines to ensure drug quality, safety, and efficacy.

Investigational Device Exemption (IDE)

FDA authorization allowing an unapproved medical device to be used in a clinical investigation to collect safety and effectiveness data.

Investigational New Drug (IND)

An application to the FDA to begin clinical trials of a new drug in humans.

Investigator's Brochure (IB)

A comprehensive document summarizing clinical and nonclinical data on an investigational product for clinical trial investigators.

ISO 14971 (ISO 14971)

The international standard for application of risk management to medical devices across the full product lifecycle.