Plain-language definitions of first-in-human, medical device, and Latin American regulatory terms used across bioaccessla.com. Reference material, not regulatory advice. Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD.
The first administration of a new investigational medical device or drug in human subjects. FIH studies are typically small, closely monitored, and designed to gather preliminary safety and performance data before larger clinical studies.
A limited clinical investigation of a device early in development, typically before the device design is finalized. EFS studies evaluate device design concepts with respect to initial clinical safety and device functionality in a small number of subjects.
The U.S. FDA regulation governing Investigational Device Exemptions (IDE). It sets out the procedures for clinical investigations of medical devices, including sponsor and investigator responsibilities, IRB review, informed consent, and reporting.
The FDA regulation on acceptance of data from clinical investigations of medical devices conducted outside the United States. Data may support an IDE, 510(k), De Novo, or PMA submission when the study was conducted in accordance with Good Clinical Practice and the FDA is able to validate the data.
The international standard for clinical investigation of medical devices in human subjects — Good Clinical Practice. It defines the design, conduct, recording, and reporting of clinical investigations to protect subjects and ensure the scientific credibility of the data.
A statement of ethical principles for medical research involving human subjects, developed by the World Medical Association. It is the foundational ethical framework referenced by most national regulators and ethics committees worldwide.
The International Council for Harmonisation guideline on Good Clinical Practice — an international quality standard for designing, conducting, recording, and reporting clinical trials in human subjects. Compliance with ICH E6 is a prerequisite for FDA acceptance of foreign clinical data.
An FDA authorization under 21 CFR 812 that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data required to support a marketing submission.
An FDA authorization under 21 CFR 312 that allows an investigational drug or biological product to be shipped across state lines for use in a clinical trial before a marketing application is approved.
An FDA premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device not subject to premarket approval. Most Class II devices reach the U.S. market through the 510(k) pathway.
An FDA pathway for the classification of novel medical devices of low to moderate risk that have no legally marketed predicate. A granted De Novo request creates a new device classification and can serve as a predicate for future 510(k) submissions.
The most stringent FDA device marketing application, required for most Class III devices. PMA approval is based on a determination that the application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
A formal FDA mechanism within the Q-Submission program by which a sponsor requests written feedback or a meeting with FDA before submitting an IDE, 510(k), De Novo, or PMA. Commonly used to align on study design, endpoints, and acceptability of foreign clinical data.
An independent body composed of medical, scientific, and non-scientific members whose responsibility is to protect the rights, safety, and well-being of human subjects in a clinical trial by reviewing and approving the trial protocol, informed consent, and related materials.
Instituto Nacional de Vigilancia de Medicamentos y Alimentos — Colombia's national medicines and food surveillance authority. INVIMA regulates medical device registration and oversees clinical trial authorizations in Colombia.
Comisión Federal para la Protección contra Riesgos Sanitarios — Mexico's federal authority for protection against sanitary risks. COFEPRIS is responsible for medical device registration and the authorization of clinical research in Mexico.
Agência Nacional de Vigilância Sanitária — Brazil's national health surveillance agency. ANVISA regulates medical device registration and clinical trial authorization in Brazil.
MINSA is Panama's Ministry of Health, and the Comité Nacional de Bioética de la Investigación (CNBI) is the national bioethics committee that oversees registration of institutional research ethics committees. Clinical research in Panama is conducted under MINSA authority with ethics review by CNBI-registered committees.
Dirección General de Medicamentos, Insumos y Drogas — Peru's general directorate for medicines, supplies, and drugs, part of the Ministry of Health.
An individual, company, institution, or organization that takes responsibility for the initiation, management, and financing of a clinical trial. Under ICH E6, the sponsor is accountable for the overall quality and integrity of the trial data.
An organization contracted by a sponsor to perform one or more of the sponsor's trial-related duties and functions, such as regulatory submissions, site management, monitoring, and data management.
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