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Old 11-15-2014, 04:02 PM   #9 (permalink)
sunsally
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Re: Your Perception of PAST ITA "plan"

Most recently, the ITA interfaced with the FDA.

What was avoided, for now, is as follows:

Quote:
Originally Posted by Robert K View Post
What was originally proposed and sought by the derms was much much worse then what we ended up with from the FDA.

The new FDA rule (Class II medical device) and accompanying policy is something we as an industry can accept. It does not place any undue financial hardships and restrictions on our industry. The ITA spent a lot of time and money making sure as best they could the outcome would not devastate our industry. This was accomplished!

What could have happened:

Each tanning bed would require a separate 510K

Tanning beds without 510K could no longer be sold

Tanning beds from manufacturers no longer in business could no longer be used

For those unfamiliar with the 510K process, see this link:


http://www.emergogroup.com/resources...arance-process
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