Do FDA Laser Regulations Apply to Components?

[QUALITYTRAINER]

I'm not sure where to look in CFR, but where does it define the scope of what is included in the Reg? I'm interested in knowing if a manufacturer of a component level laser circuit needs to register with the FDA if their component will only function once it is included in a circuit (that will then generate a laser signal).

Thanks!

 

[Ronen E]

Re: Do FDA Laser Regs Apply to Components?

I'm not sure where to look in CFR, but where does it define the scope of what is included in the Reg? I'm interested in knowing if a manufacturer of a component level laser circuit needs to register with the FDA if their component will only function once it is included in a circuit (that will then generate a laser signal).

Thanks!

Have you already consulted this:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=1040.10