What is a treatment IDE?

During the course of the clinical trial, if the data suggest that the device is effective, then the trial may be expanded under a new IDE to include additional patients with life-threatening or serious diseases. This is called a treatment IDE.

What is a compassionate use exemption?

The term “compassionate use” or “compassionate exemption” means that a patient is allowed to receive a drug even though he/she does not meet the eligibility criteria of a clinical trial in which a drug is being studied.

What is a compassionate use order?

What is compassionate drug use? Compassionate drug use means making a new, unapproved drug available to treat a seriously ill patient when no other treatments are available. Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs.

How long does an IDE take?

An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.

What is the IDE process?

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. 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.

What is a compassionate care?

Compassionate care is medical and emotional care for patients with terminal diseases, and may include hospice care. State-specific legislation, statutes and judicial rulings govern this area of medical practice.

What is required for an IDE?

All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Clinical evaluation of devices that have not been cleared for marketing requires: an investigational plan approved by an institutional review board (IRB).

What does compassionate use mean for medical devices?

The compassionate use provision provides a path to accessing investigational devices that have not received FDA approval or clearance for patients for whom the treating physician believes the device may provide a benefit in diagnosing, monitoring, or treating their disease or condition.

When does a compassionate use request IDE supplement?

When there is an IDE for the device, compassionate use request IDE supplements have the same statutory 30-day review cycle as other IDE submissions. However, the patient need is considered when reviewing these requests.

What does IDE stand for in medical device category?

An IDE is issued by the FDA to allow the use investigational devices in human subjects. The IDE permits use of the device in a clinical investigation to evaluate the safety and/or efficacy of the investigational medical device. An IDE may be held either by a commercial sponsor or by a physician-investigator.

Do you need an IDE for an investigational device?

More information is available at this site: http://www.fda.gov/. If an investigational device is a “non-significant risk device”, an investigator does not need to submit an IDE; the IDE will be “considered approved” under FDA regulations.

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