requirements for fda 510k, page-10

Jakem,

I had read this ann dated June 5th, is this what you are referring to?

Cheers Greg

HARRINGTON’S ILLICIT DRUG TESTING PRODUCTS RESUME MARKETING IN THE U.S. MARKET
The Company advises that following discussions with the US Food and Drug Administration (FDA) regarding the marketing of drug testing products that have not received 510(k) clearance in the U.S. The FDA has confirmed that the Company’s products, including the saliva illicit drug screening device OraLine may be distributed for use by; law enforcement agencies, medical examiners, within the U.S. court system where defendants are regularly tested, in correctional and juvenile detentions centers and for use by parole and probation officers.
The FDA acknowledged that they were aware that none of the saliva drug tests presently available in the U.S. currently have 510(k) clearance. They stated that as a general principal the FDA endeavor to maintain parity in dealing equally with all parties who are not in compliance with published guidelines, however they did not provide any advice as to how or when they would address non compliant competitor saliva tests.
The Company is committed to regulatory compliance and has recently completed an independent compliance audit. Acceleration of activities required to achieve 510(k) clearance facilitating the broader marketing of the Company’s products and particularly of OraLine to the workplace continues. The Company will meet with the FDA this week to ensure that proposed studies meet the regulator’s requirements, and is optimistic that filing for all products including OraLine could occur as early as July. With no saliva testing having attained 510(k) clearance the Company views the matter of compliance for its OraLine product as a strategic imperative that will provide a significant competitive advantage in the U.S. and other markets and all available resources are focused on delivering 510(k) clearance in the shortest practical timeframe.
It should be noted that the sale of the Company’s products will continue uninterrupted in all other global jurisdictions, particularly in China where the Company’s OraLine product has recently received formal certification and represents China’s only approved and certified oral fluid illicit drug testing product.