Short answer-
To determine risk of injury, a hazards analysis is usually performed early in the requirements-setting time frame to ensure that any benefits of the risk analysis can be available for incorporation to any design prior to choosing the modality of the design.

A hazards analysis is a technique required for medical device creation.

Burns can be anything from erythema (redness) to fourth-degree burns. A proper team including physicians and other care-givers (nurses) should be brought together to review all potential hazards of a given device. It should be managed by someone with experience in running hazard analyses.

If the HA is performed after design decisions have been made, delays are incurred because you CAN NOT ignore the results of the hazards analysis without severe repercussions. Hazards must be either eliminated, mitigated, or be outweighed by benefits. Example of the last -the defibrillator may burn the subject, but it saves the subject's life.

By performing the HA as part of design assurance (formal development following FDA regulations) and an 'overall development life-cycle' you may make certain claims of safety. Note that this is a hugely complicated process and requires serious expertise.

In addition, there are also safety standards such as UL which are achieved through testing, but that alone is insufficient for medical devices marketed in the US.

Thanks for that generous answer, Steven!

Kaushik Lodh Thank you for the comment Steven. We have done risk analysis per ISO 14971, and we have done a million ASTM / safety tests and certifications.

I had not heard of this "Hazards analysis" before.

Any labs which perform Hazards analysis for money? Can we do it ourselves? Do medical practitioners have to sign off on it?

Keep in mind, we are not a Medical device. Just a consumer electronics device.

Where does the Hazards analysis fall in the picture of the FDA compliance process (if we go for it in the future)?

Bruce Youngman Hazard analysis would be part of your design controls both for input on the design as well as tied to verification that the product performs as designed. This is part of 21 CFR 820.30 for design controls. Not knowing what the product is, you state you are not going for FDA compliance, my advice would be to do some checking to make sure your product(s) would be considered exempt. Contacting someone at the FDA would be helpful in this manner to determine if your product is or can be considered a medical device. If you are not in the US, you could review the EU Medical Device Directive (93-42-EEC) regarding CE marking.

Kaushik Lodh Thanks for the comment Bruce. We are making a parenting aid infant pulse oximeter. Not a medical device.

I am not directing my comments (as below) to any one, just sharing my thoughts.

I am familiar with the 21 CFR 820 regulations. It does not specify anything about Hazard analysis, let alone medical professionals certifying that the product does not cause any injury.

I feel the above, would be prohibitively expensive and time consuming for a start up.

To be reasonable : our only concerns for injury is red marks due to the sock (worn by an infant) on which the pulse ox is placed or any battery malfunction. We have the UL 1642 certification for the battery, and we are not concerned about the battery over heating or exploding. We have safety features in place. And red marks from the sock can be alleviated by parents choosing the correct sock size. Also we use natural materials for our socks.

I doubt every garment manufacturer has to take t-shirts / pants or (as relevant here) socks through an approval process from Medical professionals.

We have not yet gotten around to Round 1 financing yet, and are shipping to backers and beta testers at present. We cannot spend thousands on "nice to have" tests, which potentially do not add value to the product.

While I understand the need and concern for safety. We have a realistic concern that we need to pay salaries and ship products.

We have design assurance in place, QA and ISO 14971 style risk analysis. Is it perfect? No! But it is a work in progress. As we have more money, and our product hits the shelves we will invest more towards a formalized process. But as of right now, it is what it is.

My question came, since a doctor wants to use our product. And he wants some thing that says the product won't cause injury to the IRB.

Not exactly sure how we can reply to this doctor. I have asked my staff to list the test data we have obtained from 100+ patients, safety certifications (ASTM, etc) with the relevance of these certifications explained in simpler terminology, and state that we are following ISO 14971 risk analysis methodology and QA process (without filing to FDA).

I guess this is a question we will be asked quite often. But at the same time, our primary concern is parents, not doctors. We are not a medical device.

Stephane Morvan Regarding burns, rashes etc... you might want to show the Doctor test results based on ISO 10993. The tests you are looking for for are irritation and sensitization (ISO 10993-10).

This link might be relevant, although this is only a draft: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf

Just be aware that the exact nature of the tests you are carrying is very important and is based on the material you are trying to test.

In practice Doctors are not at all familiar with ISO 10993 test results, so showing him a detailed report is a double edge sword: on the one hand this may prove sufficient, on the other hand this may bring additional questions if the test report is not understood... So you might also want to ask the laboratory who will perform those test to also give you a 1 page test summary of the test results specifically intended to be shown to Doctors.

If you are not seeking FDA compliance: does this mean that your device is not considered a medical device?

Even if you are not seeking FDA compliance, it may very well be that one day you will, so consider checking all the boxes for the lab tests (and assuming the extra cost) to ensure that those test results can be used to gain FDA approval... And even then the FDA may reject those tests because you weren't cGMP/ISO 13485.

Aaryak Joshi Hi Kaushik, below is the link to the guidance document on pulse oximeters, I would re-emphasize on the question that Stephane mentioned - are you sure that your product is not defined as Medical Device by FDA. If your product falls into the definition as mentioned in the guidance I am referring, then it will be a prescription device. that means it would require FDA review and clearance. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081352.pdf
The guidance outlines what needs to be done.

On Hazards Analysis.... 14971 asks the manufacturers to review risk possibilities, identify and establish ways to safeguard or mitigate them at best.... at every level in the process from concept to End of Life of product..for the robustness and safety of the product it can be done internally, but some type of testing like environmental factors like and human factors, for ex if the product is home use device, some external support may be needed....

Medtech Cos do not go for 14971 certs, it is incorporated within 13485 and mostly medtech cos go for 13485 certs, so it covers it there, again for part 820 you do not get certs...however if you implement any of these it will somewhere indicate that the product is medical device. Again Certs and Standards do not "guarantee" safety..they only are frameworks for "at minimum". So there is an area of risk which is not inclusive in any of the certs or standards explicitly, the product owner is liable to ensure that a robust risk/hazard analysis framework is established and maintained to remove, mitigate, monitor risks....in addition to "at minimum"

And if the product is medical device by the definition of FDA when in commercial use within USA, then the possibility of getting the "FDA compliance" or "Clearance" later would never be advisable.

Hope it helps..

Aaryak Joshi and with reference to the question by the doctor, that he/she needs to submit a safety analysis to IRB, .....assuming that it is for a study that you wish the doctor to conduct and collect data on the usage....the IRB would require a specific type of document, which in general incorporates the elements of a IDE application,....

If that is the case what you can do immediately is get a medical expert/writer, who has experience in writing product dossiers for medical product studies, who will do proper analysis and compilation of the available information and test data, to be submitted to IRB for their approval, then the IRB will decide whether all the risks have been identified, as possible, have they been addressed and at best mitigated, and while every product has risks and benefits, if the available risks are significant/non-significant ........... then if they determine there may be significant risks, you will have to go to FDA....I am saying all this based on many many assumptions, and considering your product a Medical Device.

Plz do not consider this a professional advice. Do let me know if it helps.

I think you need to do the following.

If you plan to sell (market) this device in the US, you must classify the device.
The first thing you need is seek legal instructions from counsel expert in FDA law, or, seek the advice from the FDA directly, I suggest an Attorney for business reasons only, you can seek help from the FDA, but I wouldn't do that without the help of either legal or regulatory council.

You can not afford to avoid this first step, -the FDA can stop you from marketing, selling, or importing what they consider to be medical devices into the US.

1. is nice, but it is not what is required to market a device in the USA, you must determine whether the FDA would consider this to be a 'medical device'. If they (the FDA) consider this to be a medical device, it is. Then you are subject to working under the Medical Device Amendments of 1976 and the numerous updates since then, including Device Establishment Registration and the approvals processes.

There are three types of devices, class I, class II and class III, Pulse Oximeters usually fall into class II. There is so much more to this its not funny. Seek counsel of the FDA directly, -or regulatory experts/law firms that can represent you to the FDA. Going on this website to get guidance is good, but not sufficient.

The "1" in paragraph 4 should be "14971", the web page changed it when I added my comment.

Have you established if there is a predicate device? That may be a good reference to start with.

Predicate devices are necessary for class II devices, which undergo Premarket Notifications ( 510k's ) submissions.

Go to the FDA website www.fda.gov and do a search on "510k" for further regarding premarket notifications, and a searchable database of previous 510k's.

I agree with Aaryak that a familiarity with ISO 14971 would go a long way to help you understand hazard analysis of a device.

Richard Schrenker As noted above, if your only intended use for this device on humans is to support IRB-approved human studies, and you do not intend to sell it on the open market, then you might be able to avoid FDA regulation. My experience has been that an IRB will determine what safety issues a device has to address for use in a study it approves. IRB requirements can vary by organization.

I just searched the web under "pulse oximeter for babies regulatory status" and found the following: http://www.fda.gov/RegulatoryInformation/Guidances/ucm341718.htm. There plenty of other links there as well.

After 36 years in on the hospital side of the medical device field (this week, in fact), I think I'm pretty good at recognizing a medical device when I see one described. I will be extremely surprised if what you have described is not a medical device. But I'm not a regulator, so I'm open to surprise.

But as a parent and a grandparent with my background, there are few things that would upset me more than finding out a company skirted laws focused on the demonstration of safety and effectiveness to bring a device to the market a device that parents and grandparents could be led to believe they could depend upon as providing indication of the well-being of their child. If I ever learned that such a device was being marketed, I would immediately notify the FDA. I would not wait for a failure of the device, because I would not want it on my conscience if I were to find out later that a family lost a child because of a failure associated with the device. So I will be watching for this.

The laws governing this domain are not primarily built around what a manufacturer can afford. But that is taken into account in the regulations, and thousands of manufacturers adhere to them. But even if they were first about cost, manufacturers can and do talk with the FDA for free. Ditto with IRBs.

Bruce Youngman Kaushik thanks for expanding on what the product idea is. You just received a trove of some valuable feedback all of which can help "frame" you product within the variety of potential regulations it may need to comply to. Follow through on these leads and how they relate to what you are doing

Julie Omohundro Ummm. why, exactly, is this not a medical device?