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Glossary of Terms

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IDE

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)’s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Implant

Implant is a device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain there for a period of 30 days or more. In order to protect public health, FDA may determine that devices placed in subjects for shorter periods are also implants.

In Vitro Testing

Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.

In Vivo Testing

Testing conducted in living animal and human systems.

Inclusion Criteria

A list of criteria that must be met by all study subjects.

Informed Consent

The voluntary verification of a patient's willingness to participate in a clinical trial, along with the documentation thereof. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternative therapies available, and of the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.

Institution

Location of research. Retains ultimate responsibility for human subject regulation compliance.

Institutional Review Board (IRB)

An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB's responsibility to ensure that the study adheres to the FDA's regulations.

Investigation

Investigation is a clinical investigation or research involving one or more subjects to determine the safety and/or effectiveness of a device.

Investigational device

Investigational device is a device, including a transitional device, that is the object of an investigation.

Investigational device exemptions (IDE)

IDE refers to the regulations under 21 CFR 812. An approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21 CFR 812 are met.

Investigational New Drug Application (IND)

The petition through which a drug sponsor requests the FDA to allow human testing of its drug product.

Investigator

A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational device is administered. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.

Investigator's Brochure

Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.

ISO 14155-1:2002

An international standard that defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to protect human subjects, ensure the scientific conduct of the clinical investigation;and assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.

IVDs

IVDs are medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. The device classification for these devices can be found under 21 CFR 862, 21 CFR 864, and 21 CFR 866.

Longitudinal Study

A study conducted over a long period of time.

Master file

A reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.

Medical Device Amendment

An amendment to the Food, Drug, and Cosmetic Act signed into law on May 28, 1976. The amendments gave FDA authority to regulate medical devices.

Monitor

When used as a noun, monitor is an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor, or a consultant to the sponsor, or an employee of or consultant to a contract research organization. When used as a verb "monitor" means to oversee an investigation.

Monitoring

Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, GCP and by regulatory requirements.

Multiple Project Assurance

Permit given to institution for multiple federally funded research grants for a specified period of time. States institution retains responsibility for all research involving humans and that the institution must have an established IRB.

National Institutes of Health (NIH)

Agency within DHHS that provides funding for research, conducts studies and funds multi-site national studies.

National Research Act

Act created by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent.

New Drug Application (NDA)

The compilation of all non-clinical, clinical, pharmacological, pharmacokinetic and stability information required about a drug by the FDA in order to approve the drug for marketing in the U.S.

Nuremberg Code

As a result of the medical experimentation conducted by Nazis during World War II, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.

Off Label

The unauthorized use of a drug or device for a purpose other than that approved of by the FDA.

Office for Human Research Protection (OHRP)

A federal government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions.

Office of Communication, Education and Radiation Programs (OCER)

The office of FDA/CDRH that reviews PMA labeling.

Office of Device Evaluation (ODE)

The office of FDA/CDRH responsible for the review of marketing applications.

Office of Regulatory Affairs (ORA)

The Office of Regulatory Affairs is responsible for facility inspections of FDA regulated establishments. ORA employees are located in FDA headquarter offices and in more than 150 offices throughout the U.S.

Office of Surveillance and Biometrics (OSB)

The office of FDA/CDRH responsible for statistical review of marketing applications and postmarket surveillance.

Orphan Drug

A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs.

Over-the-Counter (OTC)

Drugs or devices available for purchase without a physician's prescription.

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