Hi! By the nature of your question and comments added about electrical safety, I am assuming that the device is: An electronic device ( with Off-the-Shelf Software/Firmware? or software code customized for your specific application?).
I didn't see that you mentioned anything related to Software, so I am assuming that the device is no software controlled. Although you are not providing the Device Intended Use (which makes it difficult for anyone to give you suggestions about testing), I also agree with Stephen. Based on the limited information provided, IEC 61010-1 seems to be the most suitable electrical safety testing standard to use for testing your device.
Important considerations provided by FDA that you can use as a reference to write your assessment.
- "The risk determination (SR or NSR) is based on the proposed use of a device in an investigation, and not on the device alone."
- "What is the nature of the harm that may result from the use of the device? "
Each time that I have to write a Safety Assessment, or a justification of why the device is not NSR, I review FDA Guidances or regulations, and I use wording similar to the wording included in the guidance. In your case, I would write something like this:
Rationale for NSR Device:Per 21 CFR 812.3(m), the "x" investigational device meets the definition of a Non- Significant Risk Device. The "x" device is considered
Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects intended to be used by the subject in an office environment, and under supervision of the CRO staff. The "x" device is
NOT intended to be used as:
• An implant that presents a potential for serious risk to the health, safety, or welfare of a subject;
• Purported or represented to be for use supporting or sustaining human life that presents a potential for serious risk to the health, safety, or welfare of a subject;
• For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
I do have a lot of experience on writing safety assessments, however, I need to know your device's intended use (this is not considered confidential information, a large list of intended uses is available on FDA's website).
A safety assessment is written
after you complete the Safety Testing applicable to your device. I guess you can write it before completing the testing, but you need to have very clear, and formally documented in a test plan, what kind of testing you are going to complete.
Note: The fact that you are using
off-the-shelf electrical components to assemble the device, does not justify not to complete Safety Testing. Yes, you have to complete Electrical Safety Testing to evaluate and confirm that the entire system works as intended.
My recommendation is to search for similar devices approved or cleared by FDA. You can find files with the testing that they have completed.
Best of luck to you,
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Nina Joyce
Bay Village OH
United States
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Original Message:
Sent: 01-Jul-2019 19:57
From: Anonymous Member
Subject: Testing requirements prior to initiating medical device clinical trial
This message was posted by a user wishing to remain anonymous
Hello all,
I have a question related to testing requirements prior to initiating a clinical trial.
We'd like to conduct a pilot study for a prototype class 1 device to determine efficacy. The device is to be used by the subjects in the CROs office (will not be brought home with subjects).
I was wondering what type of electrical or safety data the IRB would require, and was informed by the IRB that we must provide a safety statement and justification as to why the device is not NSR.
Does anyone have experience in what typically goes into a safety statement? I've reviewed ISO 14155 Annex B for info that goes into the investigator's brochure, and see safety-related items there (for example, electrical, mechanical, reliability, biological safety, design calculations, etc).
If various off-the-shelf electrical components are used/assembled into the device, does this typically require electrical safety testing, or can justifications related to design and use of off-the-shelf components be made?
Any advice is much appreciated!