FDA and CE Certification process


February 2017

L.O.M. is well along its way towards achieving FDA certification in the USA and CE Marking in Europe. This is an established, detailed process that L.O.M. is required to follow that does take a certain amount of time to complete. We are working with CE Certification Experts, Smithers Viscenes Ltd., KDL Group and Symbient Product Development to complete the FDA and CE certifications for the LOM 3 ml syringe.

• LOM has entered into a proposal in agreement with CE Medical in The Netherlands and Smithers Laboratories in the UK to begin the testing of the 3 ml syringe for certification applications.

• In December 2016 a number of syringes were delivered to Smithers for their initial review.

• The LOM 3 ml prototype molds, other specialized equipment and the cylinder of propellant gas have been delivered to KDL Group, our Original Equipment Manufacturer, in China. This enables KDL to manufacture the required quantity of syringes for the certification process as well as a quantity for pre-marketing to potential distributors.

• Symbient, in California, has produced the required 300 syringes to conduct their Technical Data and Risk Analysis. These test results are required for the certification applications.

The Board would like to thank our shareholders for their continued support and patience in this matter.

On Behalf of the Board
Herbert Towning
President and CEO

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