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FDA Compliant importers

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ElektroFreak

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Yup seconded.. maybe sticky material actually.
 



ShortyInCanada

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So Dan, you need to politely remind people that you are NOT a salesman, but a product promoter. (In the real sense of the terminology.)
I'm frequently put into the same sort of position where I work. I am officially the warehouse operations, practically the everything BUT sales guy, and still have to help out frequently on the sales floor. For me, to be able to approach a potential customer and tell then up front that I will not sell them anything (as I am not able to enter a sales order) is a valuable tool for disarming them and getting them to tell me what they are looking for.
Then I am free to suggest things to them and tell them some of what I know about the products they are looking at. As a non-salesman I a free to offer any opinion or comments about everything which quickly becomes a powerful connection with a customer. They always respect an unbiased and honest viewpoint. Even if I end up suggesting somewhere else for their particular needs.
I have seen some of those very people back here again for their next purchases as they feel comfortable with the service they received.
So keep the title straight, and don't forget to keep us up to date on the info you can provide. (I think I'm going to copy and paste some of this stuff into a document file for myself...)
:san:
 

ElektroFreak

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A small update to a nice change in CDRH policy:

As of September 1, 2011 the requirement described in Attachment A of your variance approval letter has changed as described below. Item number 13 has been revised to cover maintenance of records.
13. The finn or person to whom this variance is issued shall maintain complete records of all show itineraries with dates, locations, operator name, and contact information clearly and completely identified. Records shall contain the specific equipment used, a basic description of proposed effects and a statement of the maximum power output used.
These records shall be available to the Food and Drug Administration upon request.
Item number 14 has been added to cover notification of other agencies.
14. Advance written notification shall be made as early as possible to appropriate Federal, State, and local authorities providing show itinerary with dates and locations clearly and completely identified, and a basic description of proposed effects including a statement of the maximum power output intended. Such notifications shall be made, but not necessarily be limited, to:
(a) The Federal Aviation Administration (FAA) and the Department of Defense (DOD) for any projections into open airspace at any time (i.e., including setup, alignment, rehearsals, performances, etc.). If the FAA or DOD objects to any laser effects, the objections shall be resolved and any conditions requested by FAA and DOD will be adhered to. If these conditions can not be met, the objectionable effects shall be deleted from the show.
(b) State and local radiation control offices/agencies for all shows to be performed
within their jurisdictions. All requirements of State and local law shall be
satisfied and any objections raised by local authorities shall be resolved or the
effects deleted.
The effect of this change is to remove the requirement to send CDRH advance written
notification for every laser-light show. -Instead records of each show shall be maintained and available for FDA review upon request.
If you have any questions please contact: Robert J. Doyle at: robertj.doyle@fda.hhs.gov or 301.796.5863.

Center for Devices and Radiological Health
 
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qumefox

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Nice info EF. There really should be a dedicated stickied thread here in the lasershow section that itemizes and lists exactly what's required to get and maintain a variance for a DIY projector.
 

ElektroFreak

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This thread has such a large amount of that info in it that I had hoped it would fill that niche.. much of the info is here, if not almost all of it, albeit spread over the thread. If this proves to be too hodgepodge I'll start on a dedicated thread like you describe.
 

qumefox

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Well I was really referring to a concise itemized list that's all together in one place, and easy to find, and most importantly, written by someone who's actually completed the process successfully so it's not just a bunch of guesses. (which rules me out at the moment, heh)

I think it should contain;

1)Minimum design features of a DIY projector needed to get approved, and possibly other features that are optional, but may help with easier approval

2) A list of all the appropriate forms required, possibly with links to said forms as well.

3) A rough timetable of roughly how long the process may take

4) Possibly examples (fictional of course) of things like product reports, etc, depending on how much time the creator wanted to spend on this post, to be used as guidelines as to what exactly the FDA is wanting, information and formatting wise.

5) Any known restrictions and pitfalls in the process, or show designs, etc, to watch out for.
 

ElektroFreak

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I like that idea.. I'll talk to my partner to see what we can disclose. I would imagine I can give you just about any information we have, but I want to be sure by running the idea past the legal/IP guru.

The nice thing is that the letter in my last post eliminates one of the most annoying parts of the process, IMO at least.

But then again IMO all CDRH regulation of laser shows is unnecessary based on injury reports (worldwide) from entertainment events utilizing lasers. It's just not very hazardous.. even the high dB levels from the sound arrays at concerts are more dangerous based on statistics. Of course this is just my opinion, but it's my hope that the CDRH is starting to realize this as well, and in turn realizing that their time is better spent elsewhere.
 
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qumefox

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I just think the easier it is to 'get legal', the better off the hobby will be in the long run. And getting the proper variances is one thing there's a lot of confusion over.
 

ShortyInCanada

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I might add another item to Qumefox's list.
Links to the various state's agencies that are involved. It would require breaking the lists down to state by state after giving the federal links but then your page would have just about everything needed for the hobbiest through to the professional to be able to legally register and operate their own units.
To be able to find all regulations, the layman's interpretations of those regulations, the necessary forms and the addresses of the relevant state agencies would be awesome. (For you in the US.)
It would also be very helpful for us Canadians, like I have stated before, as if we follow the rules and regulations for the country with the strongest standards then we end up with a superior product ourselves that we can safely operate across the border if the need arises.
Good job here.
 
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