Docket Management
Docket: 98N-1215 - Foreign Establishment Registration and Listing
Comment Number: EC -4

Accepted - Volume 2

Comment Record
Commentor Mr. Paul Billiet Date/Time 2002-01-10 04:26:27
Organization Visys AG
Category Company

Comments for FDA General
Questions
1. General Comments Dear Sirs, Dear Mr. Philip Chao, Our company submitted on OCTOBER 9th, 2001 1. an INITIAL REGISTRATION OF THE DEVICE ESTABLISHMENT (Form FDA 2891) 2. a DEVICE LISTING (Form FDA 2892) numbered << Document number C 021679 >> The classification name of the device listed is << AID, VISION IMAGE INTENSIFICATION >> with << HOT >> as classification number. Our case is rather simple: our product concerns a help for visually impaired people, in the form of glasses. The filing of registration of our company as well as of the device, as said:entered on October 9th, 2001, has been done in due form, in conformity with regulations. Up until now, we have been awaiting, in vain, for a registration number. We believe that such could have been executed in at least 4 to 6 weeks time... Great is our surprise, when we hear that regulations have in between (nov.27 2001)changed with regard to the requirement to have a US agent. Moreover: one sole agent. Our product, as said rather simple, comparable to a pair of glasses or to a head-mounted device, finds diverse applications, in diverse market segments: - law enforcement - leisure activities (yachting, hunting, hiking,...) - virtual or augmented reality (edutainment, vision aid for professional duties such as mechanical mounting, instructions' sessions, image-guided surgery or minimal invasive surgery ...) - the segment of the visually impaired, FOR WHICH PARTICULAR SEGMENT THE REGISTRATION HAS BEEN DEEMED TO BE NECESSARY With regard to these different market segments different approaches are needed. Our company, VISYS AG, a young company, intends to build a network of specialised distributors in the US, each for their special segment. Visys is in the process of doing so. As things evolve now, it appears that different US organisations would (or could) take care of different market segments... - distributors of consumer electronics for consumer applications - specialised distributors for medical applications - specialised organisation to cover the needs for visually impaired - specialised dealers to deal with police forces etc... for law enforcement applications It is therefore contrary to the logic, and surely driving up costs in an unnecessary way to designate one sole agent. Such agency would in fact play a role as « simple mailbox ». It would be situated in between Visys and the real distributors (those that will perform the real work). It will only exist because of the administrative red tape ! It would be receiving fees for doing nothing but complying with a burdensome regulation. And such is precisely NOT what the regulation was meant to be. The regulation even forbids the use of a mailbox agent... Therefore we object in principle to this change of regulation. If nothing can be done to overturn it, we have following questions. 1. can we swiftly obtain REGISTRATION based on the regulation that are still in vigour now (Note: the rule is effective Feb.11, 2002 only...)? We could then care about adequate amendment of the registration afterwards... 2. an even more important question: judged upon the type of product, is FDA registration überhaupt ? , anyway ? necessary ? It may be that in reality this type of Vision-Aid product does not require registration. After all, it does not concern neither FOOD, nor DRUGS... We sincerely hope to obtain a return reply with a satisfactory solution. Kind regards, Paul Billiet project engineer VISYS AG tel +49-6172-96.80.45




EC -4