Conducting Investigator-Initiated Clinical Investigations of Devices

Question 1

off label use approval

Answer 1

f a physician uses a product for an indication not listed in the approved labeling (that is, “off-label”), the physician has the responsibility to be well-informed about the product and to base the proposed use on scientific rationale and medical evidence.

Question 2

Investigator

Answer 2

an individual who actually conducts a clinical investigation

Question 3

Device

Answer 3

instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory

Question 4

device?: software functions in US

Answer 4

are not devices

Question 5

Sponsor

Answer 5

entity that takes responsibility for and initiates a clinical investigation

Question 6

Use of Device Without Informed Consent

Answer 6

If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within five (5) working days,” and the sponsor-investigator must notify the FDA within five (5) working days after receipt of the information (21 CFR 812).

Question 7

Deviations from the Investigational Plan

Answer 7

to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible,” but not later than five (5) working days after the emergency occurred (21 CFR 812).