FDA certification for laser product

1. Introduction FDA is the abbreviation of the US Food and Drug Administration. It is responsible for the certification of human health related to food, medicine and medical equipment in the United States.

    

   The United Testing could do the FDA certification for laser products, which is compulsory certification.

    

   The certification operation process as following:

   1). customers provide 2 testing sample

   2). Providing detailed technical parameters of the laser products, our engineers fill out the FDA detailed questionnaire, the questionnaire is submitted to the US FDA, after the approval, the FDA issued a copy of the approved fax, This fax is the so-called FDA certificate.

    

   Documents required for FDA certification

    

   Instruction manual; 

   Circuit diagram;

   Specification of pick-up unit (including the range of wave length) movement specification, laser wavelength range;

    Laser path diagram light path diagram;

   Marking label nameplate label (see below Example);

   Specification controls for critical components;

   Manufacture and assembly control procedure;

   QC inspection and testing control procedure QC Quality assurance testing control process; Assembly and test traveler forms Assembly and test circulation Table;

   Inspection and thest reports and checklists;

   Life and endurance test records Overall life test (eg durability/environmental test) status record (record contains test method and deformation/mechanical strength of the outer casing/ Reliable inspection of component connections);

   Two complete sample Two complete machine samples;

   US agent information: agent name, address, contact name, position, email, contact number, fax; MARKING LABEL EXAMPLE nameplate label Like (Product) (Model);

   Production flow chart