Thanks Lauren

 

The final product is a kind of industrial measurement device and it contains a 
laser device which is bought from an external manufacturer.

Right now, I do not have any information about the laser device, but I wonder 
if this paragraph might be applicable:

 

§ 1040.10 Laser products.

(a) Applicability. The provisions of this section and § 1040.11, as amended, 
are applicable as specified to all laser products manufactured or assembled 
after August 1, 1976, except when:

 

(1) Such a laser product is either sold to a manufacturer of an electronic 
product for use as a component (or replacement) in such electronic product, 

 

 

I suppose the manufacturer of the final product should not deal with 21 CFR § 
1040.10 and instead be aware and purchase laser devices which are ready tested 
and approved according to this regulation. Agree?

 

 

Best regards

Amund

 

 

 

 

-----Opprinnelig melding-----
Fra: [email protected] 
Sendt: 19. mai 2020 16:26
Til: [email protected]
Emne: Re: [PSES] 21 CFR § 1040.10 - Laser products.

 

Hi Amund, 

 

It's been a key aspect of my work for several years. It can be quite 
challenging. Terminology and meaning are a little tricky. The amount of time 
consumed sort of depends on whether you are dealing with a product that fits 
nicely 'between the lines'. 

 

Regards,

-Lauren

 

-----Original Message-----

From: Amund Westin < <mailto:[email protected]> [email protected]>

Sent: Tuesday, May 19, 2020 3:17 AM

To:  <mailto:[email protected]> [email protected]

Subject: [PSES] 21 CFR § 1040.10 - Laser products.

 

Anyone who have been through the process for complying to 21 CFR § 1040.10?

Time consuming process?

 

BR

Amund

 

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