Regulatory agency approvals

[tareko]

Regulatory agency approvals will have to be gotten from the following agencies:

• [ ] FCC ???
• [ ] U/L ????
• [ ] Health Canada
• [ ] FDA ????
• [ ] CE ???

[amashari]

I think there is a "natural"/optimal sequence to these approvals which must already have been worked out by others

On 14-05-25 04:45 PM, Tarek Loubani wrote:

Regulatory agency approvals will have to be gotten from the following agencies:

• FCC ???
• U/L ????
• Health Canada
• FDA ????
• CE ???

— Reply to this email directly or view it on GitHub https://github.com/FreeMedicalHardware/pulseox/issues/6.

[tareko]

I would guess Health Canada and FCC are easy to get. FDA is one that I think we have to think long and hard about in the initial stages, since it would involve lots of money and only really protect the devices that we manufacture.

[kliment]

CE is not an agency, neither is UL. UL is a testing lab. Here is what we need:

Electrical safety certification (easy for low voltage DC stuff, we're safe) Conducted and radiated compatibility and immunity (this is where FCC and CE rules come in). This ensures that our device does not break radio transmissions and radio transmissions do not break our device.

UL (and many others) test device compatibility with FCC, CE, and many other national/supernational regulatory agency guidelines. They have a test suite they run on any new electronic device. For devices with no radio, this runs in the single-digit thousands of dollars. It gets done exactly once, before offering devices on open market in the regulatory agency's jurisdiction. It's valid forever, but a partial test needs to be done whenever we modify the hardware of the device (software changes are excluded, except for radio devices where the radio's firmware must be certified as well).

Health Canada and FDA are about clinical/diagnostic use of a device. I don't know much about those, but they are much more expensive and harder to get. What is required (in various places) for diagnostic use?

On 05/26/2014 03:19 AM, Tarek Loubani wrote:

I would guess Health Canada and FCC are easy to get. FDA is one that I think we have to think long and hard about in the initial stages, since it would involve lots of money and only really protect the devices that /we/ manufacture.

— Reply to this email directly or view it on GitHub https://github.com/FreeMedicalHardware/pulseox/issues/6#issuecomment-44151105.

[tareko]

I spoke with our hospital's Biomed engineers. To add to these distinctions, apparently an item that needs to plug in requires more rigorous controls than an item that that is battery-operated, ostensibly because of the potential for problems of the former. In a few weeks, I will sit with them and try to figure out more about their experiences.

[tareko]

To add a bit more information here, it seems that our main regulatory approval will be via Health Canada with no need for FDA approval for our purposes at this point.

Also, I found this article about FDA vs. EU regulations for medical devices:

Regulation of Medical Devices in the United States and European Union, NEJM