FDA Approved electronics

Hi all!

I have a project that will be measuring the humidity and temperature of a raw sugar containers of 1.5 Ton. The sensor is a SHTC3 and will not be in direct contact with the sugar but will be in the surroundings inside an FDA approved case with oppening to measure the humidity and temperature.

My question is, how can I prepare the PCBA so it can comply with FDA standards? Is there a conformal coating that I can apply to the PCB that is FDA approved?

All comments/ideas are welcomed. Thanks.

Hello, Vicvicvar.

I am sorry, I am not familiar with the applicable FDA standards for this requirement. You are probably more knowledgeable about that matter than we are. We have options for conformal coating here: https://www.digikey.com/short/r8z0zhd5, but unfortunately we have no way of searching or filtering by FDA approval. To the best of my knowledge FDA approval is always contingent on where, how, and when a given product is being used; I don’t think they do blanket “this is always safe for everything no matter what” approvals. Your solution would likely need to be tailored to the specific FDA requirements you’re trying to meet rather than trying to bank on a blanket approval.

I would think that being inside a case would address most concerns, particularly if a person were to use some type of PTFE membrane filter or such to prohibit direct contact. Protecting the circuit itself from oxidation in a moist environment would seem to me the greater concern at that point. The RTV11-1P is an example of an FDA compliant potting compound that I found, and I’m guessing there are conformal coatings and such which would carry similar approvals.

Here you will find some info about FDA regulations for PCBs.