Understanding the FCC Process with Pre-Certified Components

[semir-t]

Hello everyone,

I'm currently delving into a project that involves the use of pre-certified components and I'm trying to understand how this impacts the FCC certification process. I have a few specific questions and I would greatly appreciate any insights or experiences you can share:

1. Could someone provide a brief explanation of the FCC certification process, particularly in the context of using pre-certified components? How does it differ from the standard process?
2. What kind of documentation is required when using pre-certified components? Is there a specific procedure for reporting or demonstrating compliance to the FCC
3. Does anyone have any real-world examples or case studies where pre-certified components were used?
4. Lastly, any best practices or recommendations for someone new to this process would be incredibly helpful.

Thank you in advance for your time and help. I'm looking forward to learning from your experiences!

[CaptDon]

Are you building a transmitting device? What is your project? The certification is hugely different for different applications. For instance a washing machine with a computer board verses a 100 kilowatt medium wave transmitter. We could not even begin to relate our experience unless we know it is relevant to your application.

[jonpaul]

"Pre certified" components from China are NOT reliable as to the tests, often false or counterfeit documents.

Your product Region of market eg UK/EU/Switzerland?

USA/CA/MEX?

Asia?

Japan?

Worldwide?

range Value of product

eg EU 100 EU 1000 EU 10,000?

jon

[jwet]

Its very regional in general and involves a lot equipement classes and "it depends" as others have said. In many cases, in low volume industrial or test equipment, it is loosely enforced and often not done.   If you really are just talking about FCC, its somewhat straightforward.  A legitimate vendor will have a FCC Registration ID filed.  These are public documents available on the FCC site.  The vendor can also provide them.  The general procedure is you or an emi lab generates a report that you submit to FCC.  In most cases, the precertified module will be an addendum to your EMI test report.  Any reputable EMI lab can do the test and put a report together.  Prices vary a lot depending on the class of equipment.  You might get by for $3000 if you can work with someone.  Things get much more expensive for specialty certs like medical.  Talk to an emi lab person to person or by email.  Its a bit of a specialty like patents unless you're in a big company your project engineer and a outside firm work it out mostly.

As an FAE for Maxim, our customers (automotive especially), wanted us to precertify ic's.  This wasn't really possible, its driven by layout in most cases, we would put emi reduction features in them, controlled edges, recommended layout.  We often would take a reference design or eval board to a lab and have it tested.  These made customers feel better.  If the customer did his job, it would get through the tests. 

The FCC has an EMI FAQ somewhere that we used to point people at.  I would start by talking to a lab.  You'll get 10x smarter in a hour.

After I finished, I googled FCC EMI FAQ and found this link, this or something like it is what we'd point our customers towards.  Note that this is just FCC.

https://www.fcc.gov/engineering-technology/laboratory-division/general/equipment-authorization

[semir-t]

Thank you all for your contribution to this topic.

I guess I didn't provide more info so I will do this in this post.

The reason I am asking this question is to understand the benefits (if any) on using the pre-certified WiFi/BLE modules and how they reflect on the FCC or CE certification process.

As far as I could understand based on my search, using the pre-certified RF modules we don't have to do  a lot of testing related to the RF part (which can take few days and lot of monay). We still need to do other testing related to the EMC unintentional radiation but the number of tests we shall take is reduced as well as the time to market.
One thing that I didn't understand was located on this thread https://www.eevblog.com/forum/chat/ignore-the-fcc/msg289632/#msg289632 where one of the user posted this:

This does not seem to agree with what is in the document you linked. If there are additional switching circuits, whether intentionally radiating or otherwise, then you are likely to need re-certification. Whether your widgets includes an FCC approved module doesn't seem to make much difference here, as it shouldn't. See Scenario #2 on page 2.

and the document he was refering to is https://www.microchip.com/en-us/application-notes?rv=1234ab56

I don't understand this part and if it true then pre-certified modules don't make sense as most of my boards have some type of DC/DC converter.

To be exact, I am now working on two projects which will have to be certified:

• Consumers device with BLE and 3 switching drivers for different actuators. This one would be for USA market so FCC applies
• Medical device for EU market with BLE/WiFi capability.

Every suggestion on what to do (or not to do), or any reading material is welcomed. I am doing my research as well almost every day for 1-2 hours trying to find some good sources on this topic.


 

[jonpaul]

FCC: See FCC website and various regulations.

Medical: Depending on class (patient connected, surgical, passive, active, power source) much more restrictive regs for EMI and especially safety, mains isolation, very low AC leakage current.

Check USA laws: Your product  require USA FDA approval  to import to USA.

Any medical device mfg needs VERY GOOD USA PRODUCT LIABILITY insurance .

For sure expect lawsuits.

Our 1990s Xenon  illuminator power supply/ignitor required $1M and ONE YEAR AFTER design/proto/preprd to get approval!

Just my thoughts,

Jon

[Jon_S]

The reason I am asking this question is to understand the benefits (if any) on using the pre-certified WiFi/BLE modules and how they reflect on the FCC or CE certification process.

As far as I could understand based on my search, using the pre-certified RF modules we don't have to do  a lot of testing related to the RF part (which can take few days and lot of monay). We still need to do other testing related to the EMC unintentional radiation but the number of tests we shall take is reduced as well as the time to market.

I can't speak to FCC compliance, as I have never done that, but for CE this is not correct.

The only benefit you gain from pre-certified modules is the knowledge that it is at least theoretically possible to have a compliant application circuit using that module (they made at least one module pass, in ideal conditions, after all...).

Obviously there are an enourmous amount of ways you could take a compliant module and produce a non-compliant product. I have done that myself, had to add a pad as the radiation pattern was less than ideal and we ended up with too much antenna gain.

At my last place we had a quite nice lab where we did pre-compliance, and we even self-certified some products. But I would personally never consider the self-certification path for a Radio Product. I have seen things look not-bad in a TEM cell and then fail on spurious emissions at the OATS. I just don't believe that it is possible to demonstrate an acceptable level of confidence in compliance without proper testing.

[semir-t]

Thanks, this is interesting.

As a note, the information I found  is located here https://www.sunfiretesting.com/Top-6-Reasons-to-Use-an-FCC-Certified-Module/ under section 2.

So, if I understood correctly at the end, from the compliance side, it doesn't really matter if the module is pre-certified or not. There is not segment in the documentation where you can say: "Okay, I have the report from the manufacturer, we can skip this tests as they are done by manufacturer."

The advantage of the using pre-certified module is that you have a proof that if you follow their guide  you should be okay on the RF part even though you are not RF engineer and you don't have that much of experience with it. Because of this you get faster time to market and lower the price of the development as dealing with RF is not easy and cheap.

[dobsonr741]

If you are a small business owner/entrepreneur, or even an executive at bigger size business, the FCC is one of the area that can send you to jail, based on personal criminal responsibility. The other is Sarbens-Oxley. So don’t take FCC lightly.

Medical devices into the US: forget about it.

I’m saying as it requires such an amount of resources, that based on the fact you are posting on this forum, one safely can assume not available to you.

[jwet]

>>So, if I understood correctly at the end, from the compliance side, it doesn't really matter if the module is pre-certified or not. There is not segment in the >>documentation where you can say: "Okay, I have the report from the manufacturer, we can skip this tests as they are done by manufacturer."

That's true for FCC.  There is no short cut really.

As was mentioned, medical in US is very rigorous.  There are CLIA wavers and other ways that might help in certain cases and intended use drives the requirements- "what is effect or a false positive or negative reading".  Hire a consultant or get some real help.  Not simple.

[jonpaul]

Hello: The legal and regulatory authorities in the region will control the EMI, safety and other certifications.

The governments and potential users will ultimately hold the product  manufacturer , seller and designer of an electronic device responsible for any violation, incidents or losses.

The use of so called "pre certified" components does NOT absolve YOU of the liability or responsibility.

In a court of law the module paperwork and module mfg claims will be of no use.

Seek professional légal and EMI/safety compliance advise with a lawyer or consultant in the region of anticipated sales, ones qualified in these specialized areas.

It is wiser to NOT  place any credence in notes on a forum.

Bon chance


Jon

[semir-t]

Thank you all for valuable informations.

I feel like I was being misunderstood on some topics, so I will provide explanation.
1. Medical device is not being developed for US market.
2. For the medical device we will get the consulting company to help us with everything as I do understand that this requires an expert on the topic
3. My sole purpose of this questions was to understand the process of getting certified and how does the pre-certification affect it. I know that at the end of the day we need to do the certification but idea is to get to this point faster.

We are in a stage of selecting a components and I don't want to select the component which would in few months bite me in the a**. Because of this, we are trying to understand the process so that we in a first prototype have a good selection of components.

For example, for a medical device we need to use fuse. I don't want after few months that someone comes and says to me you need to have fuse which is IEC60127-1 certified, or you have selected the battery which is not IEC62133 certified. And these are easy to fix, just update the BOM but what if I spend hours and hours developing hardware and firmware with some RF module and then we got to the point that we understand that maybe there was a better and faster option with other module.

So ideas is to learn and understand the process and I think the community here supports this. As I said in the opening post, I would welcome and good books or any other source on the topic.

[Jon_S]

I think this forum is the wrong place to give more than the barest advice on medical device development, but I have been involved with a couple of medical products that were CE marked.

It sounds like you might be considering doing things in the wrong order, unless I have misunderstood. If you intend to comply with, say, ISO 14971 then you absolutely have to do:

2. For the medical device we will get the consulting company to help us with everything as I do understand that this requires an expert on the topic

Before:

We are in a stage of selecting a components

You must have your management processes in place before even thinking of any aspect of the design, and if those processes are working correctly they will ensure you do not specify something incorrectly. Medical development is one of the most evidenced areas of development you can do. Your processes have to be watertight first, then development can start following those processes. You absolutely cannot fit the design to the process retroactively.

[semir-t]

We do have consulting company helping us with setting the QMS at the moment.

In this stage before we complete the QMS idea was to get at least concept device which we could test to some degree and see what we can expect.

Now I think that on my side we should rethink our strategy. Thanks Jon for your contribution.