FDA compliance for manufacturers, some insight is needed

[arunb]

Hi,

I have some queries regarding the FDA compliance of laser products.

1. Is FDA/CDRH compliance needed even if the laser product is assembled with parts sourced from USA and the finished product sold outside USA (say to Latin American countries)?
2. If the laser module for the product is sourced from Digikey (USA) and the final product is assembled/manufactured in the US. Is the final assembler/manufacturer who uses this module responsible for the certification?
3. If a FDA/CDRH compliant laser module is used, then will the final product have to certified as well?

FYI: In the laser product there will be the following parts

1. Laser module (3mW power).
2. Power handling electronics (converts 12 VDC to 3.2 VDC) and also noise suppression
3. Optics, focus lens, collimating lens etc
4. Outer body of the product for housing all the above stuff.

Thanks
nm

 

[RedCowboy]

You should consult a product liability attorney as LPF is only a hobbyist site and can not give you professional legal or medical advise, however if you take advise from someone here I expect you know that you do so at your own risk, also the FDA site is a good place to start.

Laser Products and Instruments | FDA

This page contains information about laser products and instruments.

www.fda.gov

 

[arunb]

Thanks for the reply. Yes I understand completely.
Does the FDA compliance apply on incandescent lights, such as halogen bulbs used in cars??

 

[barthchris]

Thanks for the reply. Yes I understand completely.
Does the FDA compliance apply on incandescent lights, such as halogen bulbs used in cars??

The answer is no. Lasers are uniquely hazardous in that light properties can focus down to a very small, intense spot easily burning the retina. Sure, a broadband source of light (almost anything not a laser) can do this if its bright enough(nuke bomb bright) but it's highly unlikely

 

[Mattronium]

As others have noted, most here are not experts, so if this is an official product, it would need to be verified with a professional.

One thing to note is if the laser beam is fully confined. If the laser is confined, like in a dvd or laser printer, then the finished device I think is considered a class 1 product. If not confined, then for a laser under <5 mW would be class 3R. You might get a little better help over at Photonlexicon, but even then, you are going to need a professional opinion. Keeping the laser lower power, and confined I imagine would help with the regulation.
One side note to maybe consider is, if you need visibility, switching to a more visible wavelength (green/520nm/532nm) means you could use lower laser power. Might help push it into a lower classification. Probably won't need to do that though.