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Frequently Asked Questions
What is Required for an Initial Certification?

For initial certification of a laser product, the following must be true or must be performed:

·     The product must meet the performance standards for the appropriate class. 21 CFR, 1040.10 (f).  Performance features include devices such as protective housing, key switches, interlock systems, beam attenuator, labeling etc.

·     “User documentation” (owner’s manuals) must be generated or modified so as to reflect the informational requirements of  1040.10 (h)  

·     An “Initial Product Report” must be generated and filed with the CDRH.  1002.10 This is typically a 40-60 page technical document for each different model.

·     A certification test procedure shall be generated and performed on each unit being certified   1010.2 (c)

After initial certification there are additional compliance requirements such as record keeping and filing of annual reports, 1002.13.   You also need to be aware of the details about how to process, import and export units as well as other items.  Additionally, in many cases, dealers or distributors may have record keeping and reporting responsibilities. 

What is a "Corrective Action"?
Corrective actions can take many forms.  In some cases, corrective actions include suspension of product demonstrations and shipments, product recalls and retrofitting of fielded products.
What are some of the consequences of improper or incorrect compliance?

If the lasers and laser products imported into the US are not legal and fully compliant the CDRH can require the manufacturer and/or the importer to correct the problem by:

a)      Refunding the sale price of the laser

b)      Replacing the product, free

c)      Repairing the product, free

The CDRH can also fine laser product manufacturers US$300,000 for product compliance issues. 

The CDRH can also stop the importing of the products if they are not legal.  Everyday the US Custom’s office prevents laser products from entering the US because they are not fully compliant.  If the US government holds (seizes) your laser products it can easily take six months to get them released and cost thousands of dollars in fees and time.  In many cases, the products must be shipped back to the country of manufacture for re-manufacture without ever entering the US.

 

Telephone: 781-255-1064 / Fax: 781-255-1065 / email: info@bluehilloptical.com

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