Study Risk Determinations from FDA

1. Devices
2. Study Risk Determinations from FDA

Video explanation
Investigational Device Risk Determination Video explanation
Off Label Use and Risk Determination

The IDE regulations (21 CFR part 812) describe three types of device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies. For studies that are not exempt, sponsors are responsible for making the initial risk determination (SR or NSR) and presenting it to the Institutional Review Board (IRB).

FDA is available to help the sponsor, clinical investigator, and IRB in making the risk determination. FDA will review written Study Risk Determination requests from sponsors planning a device clinical study and provide a binding risk determination in writing. For more information, please see FDA Guidance for Industry and Food and Drug Administration Staff entitled, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program".

Please see FDA guidance for additional information on determining significant vs non-significant risk.

A Study Risk Determination request should include the following information:

Cover Letter

Include a cover letter that clearly identifies the submission type in the reference line (i.e., a Study Risk Determination request).

Example Cover Letter for a Study Risk Determination

Device Description

Provide a detailed device description. If more than one device is used in the study, provide a separate description for each device. The device description may include:

• Pictures of the device (where applicable)

• Engineering drawings (where applicable)

• Physical, chemical and/or biological processes/principles used by the device to generate device output, if applicable

• Physical and biological characteristics of the device output, if applicable

• Samples to demonstrate the use of the device (where feasible and appropriate)

• An explanation of the user interface and/or how the device interacts with other devices or with the user (medical professional and/or patient)

Protocol

Include a copy of the protocol for the proposed clinical investigation.

Description of Device Use

Include a description of how the device will be used, if not included in the protocol. A description of device use may include:

• The proposed intended use/indications for use

• Identification of the disease or condition the device is indicated to prevent, mitigate, screen, monitor, treat, or diagnose

• Part of the body or type of tissue to which the device will be applied or interacting

• Frequency of use

• Physiological use

Description of the Population

Include sufficient information regarding the study population, if not included in the protocol. A description of the population may include:

• Age (e.g., adult, pediatric, specific age limitations)

• Patient type (e.g., asymptomatic, symptomatic, already diagnosed)

• Whether patients will be recipients of combination treatments

• General description of inclusion/exclusion criteria

• How the clinical study population reflects the intended use population

Sponsor's Name and Contact Person(s)

This section should include the titles, address, phone number, fax number, and email address for the sponsor and additional contact person(s). If this information is included in the cover letter, then this section can be omitted.

Important Notes

In addition to one paper copy, you must also submit an eCopy of the Study Risk Determination. For information about how to comply with the eCopy program, please see FDA guidance for Industry and Food and Drug Administration Staff entitled, "eCopy Program for Medical Device Submissions."

Study Risk Determinations for products regulated by the Center for Devices and Radiologic Health (CDRH) should be sent to the following address:

Study Risk Determinations for products regulated by the Center for Biologics Evaluation and Research (CBER) should be sent to the following address: