SIGNIFICANT RISK DEVICE / NON-SIGNIFICANT RISK DEVICE FORM

NON-SIGNIFICATION RISK DEVICES

The IRB has made the determination that the device is a non-significant risk. An IDE application is not required. This study must be conducted in accordance with the “abbreviated requirements” of the IDE regulations (21 CFR 812.2(b)): (1) An investigation of a device other than a significant risk device, if the device is not a banned device and the sponsor; (2) An investigation of a device other than one subject to paragraph; (3) A diagnostic device, if the sponsor complies with applicable requirements in Sec. 809.10(c) and if the testing (i) Is noninvasive, (ii) Does not require an invasive sampling procedure that presents significant risk, (iii) Does not by design or intention introduce energy into a subject, and (iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure; (4) A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk; (5) A device intended solely for veterinary use; (6) A device shipped solely for research on or with laboratory; animals and labeled in accordance with Sec. 812.5(c); (7) A custom device as defined in Sec. 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

IRB approval is required and must be maintained throughout the investigation and informed consent must be obtained and documented.

This research study with human subjects involves a medical device that must comply with FDA regulations for informed consent (21 CFR 50) and Institutional Review Board (21 CFR 56) regulations. Investigational devices are medical devices undergoing clinical study to test the effectiveness and/or safety of the device which must be conducted according to the requirements of the Investigational Device Exemption (IDE) regulations (21 CFR 812).

The IRB is unable to determine whether this device poses a non-significant risk. The investigator must provide the following information: the sponsor's risk assessment determination; the rationale for the non-significant risk determination (why the sponsor believes the device presents no significant risk to study participants with supporting information including reports of prior investigations); whether other IRBs have reviewed the proposed study and if so what determination was made; and, if the device has been reviewed by FDA, FDA's assessment of the device's risk. The IRB may also consult the FDA for its opinion

The initial determination that a device is a significant or nonsignificant risk device must made by the sponsor. If there is no external sponsor then the principal investigator is considered to be the sponsor. If the sponsor determines it to be a significant risk device, the proposed study must be submitted to the FDA. If the sponsor determines it to be a nonsignificant risk device the proposed study must be submitted to the IRB. The IRB will make an independent determination that a device presents a non-significant or significant risk.

SIGNIFICANT RISK DEVICES

The IRB has made the determination that the device is a significant risk. An IDE application has been submitted to the FDA. A significant risk device by definition is an investigational medical device that presents a serious risk to the health or safety of the research subjects. Such a device is:

  • intended for use as an implant; or
  • purported to be useful in supporting or sustaining human life; or
  • intended for a use that is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise preventing impairment of human health; or
  • one that otherwise presents a serious risk to the health, safety, or welfare of subjects.

IRB approval is required and must be maintained throughout the investigation and informed consent must be obtained and documented. The study must be conducted in according to IDE regulations (21 CFR 812). Studies of significant risk devices present more than minimal risk; thus, full board IRB review for all studies involving significant risk devices is necessary.

The IRB has made the determination that the device is a significant risk. An IDE application must be submitted to the FDA. A significant risk device by definition is an investigational medical device that presents a serious risk to the health or safety of the research subjects. Such a device is:

  • intended for use as an implant; or
  • purported to be useful in supporting or sustaining human life; or
  • intended for a use that is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise preventing impairment of human health; or
  • one that otherwise presents a serious risk to the health, safety, or welfare of subjects.

IRB approval is required and must be maintained throughout the investigation and informed consent must be obtained and documented. This research study with human subjects involves a medical device that must comply with FDA regulations for informed consent (21 CFR 50) and Institutional Review Board (21 CFR 56) regulations. Investigational devices are medical devices undergoing clinical study to test the effectiveness and/or safety of the device which must be conducted according to the requirements of the Investigational Device Exemption (IDE) regulations (21 CFR 812).

The IRB has determined that the device, judged by the sponsor not to present a significant risk, should be categorized as a significant risk device. The sponsor must notify the FDA that a significant risk determination has been made. The study can only be conducted as a significant risk investigation following FDA approval of an IDE application.

The IRB has determined the device to be significant risk. An IDE application to FDA and FDA approval of the investigation must be obtained before the IRB will review the study. After an IDE has been obtained by the sponsor, the IRB will then review the proposed research study. IRB approval is required and must be maintained throughout the investigation and informed consent must be obtained and documented. This research study with human subjects involves a medical device that must comply with FDA regulations for informed consent (21 CFR 50) and Institutional Review Board (21 CFR 56) regulations. Investigational devices are medical devices undergoing clinical study to test the effectiveness and/or safety of the device which must be conducted according to the requirements of the Investigational Device Exemption (IDE) regulations (21 CFR 812).

This is an FDA approved device which is being used in a manner consistent with its marketing and labeling.

This is an FDA approved device which is not being used in a manner consistent with its marketing and labeling.

510(k) DEVICES

The FDA has determined that this new device is substantially equivalent to a pre-amendment device on the market as of May 1976 or a substantial equivalence claim has been made and the new device is accepted and can join the predicate device already on the market. The device qualifies as a 510(k) device.

Submit this study to the FDA for 510(k) determination. Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

Submit a copy of the 510(k) determination letter from the FDA.

HUMANITARIAN USE DEVICES

Humanitarian Use Devices (HUD) – The device being used is intended to benefit patients by treating or diagnosing a disease that affects fewer than 4,000 individuals in the United States per year. The labeling of the HUD states the device is a Humanitarian Use Device and the effectiveness of the device has not been demonstrated.

Annual continuing review is required.

Develop an informed consent specific for the use of this humanitarian use device. Eliminate all references to research from the informed consent document.

The principal investigator has / has not documented that the humanitarian use device is not being used as part of a research project or clinical investigation designed to collect data to support an FDA premarket approval application.

The device sponsor has completed a humanitarian device exemption (HDE) application. The device sponsor has documented in writing the following items: a) the generic & trade name of the device; b) The FDA HDE number (6 digit number preceded by the letter H); c) the date of the HUD designation; d) indications for use of the device; e) a description of the device; f) contraindications, warnings, & precautions for use of the device; g) adverse effects of the device on health; h) alternative practices and procedures; i) marketing history; and j) summary of studies using the device.

Device Form 11/2003