Wavelet image compression given FDA 510(k) approval to market in Pegasus toolkit 
Author Message
 Wavelet image compression given FDA 510(k) approval to market in Pegasus toolkit


Quote:
> Tampa, FL, U.S.A., October 1, 1998 - Pegasus Imaging Corp. received
> notification of FDA approval to market its PICTools Medical Compression
> Toolkit via the 510(k) Process.

> "FDA approval to market our image compression libraries...

Perhaps the FDA has changed its tune recently, but if not, I would
seriously urge you to change all future press releases. The FDA has always
been VERY unhappy with people who refer to 510(k) as APPROVAL. The FDA word
is "clearance." There is such a thing as FDA approval, but it does not come
in the form of a 510(k). All that the 510(k) process does is establish that
you're not doing anything different in kind from what the FDA has allowed
on the market before -- often simply because the product to which you claim
equivalence occupied a product space that the FDA did not use to regulate.
Since the FDA did not keep that company from selling their product, they
can't bring themselves to stop you, either. No FDA endor{*filter*}t is implied,
and they frown on your suggesting that it has been given (by, e.g., talking
about FDA "approval").

On the other hand, some products actually get FDA approval. That means that
they have established to the FDA's satisfaction that the product is not
only safe, but efficacious for the medical use to which it is being
applied. This requires the company to do lenghty and expensive medical
research before approval is granted. This is not a 510(k) process.

Failing to understand the language of the field does not engender
confidence in your product. FWIW.



Tue, 17 Apr 2001 03:00:00 GMT
 
 [ 2 post ] 

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