Murdok and anyone else reading,
Does anyone know whether CSO has applied to the FDA using a PMA (Pre Market Application), or a 510(k) application? If a company is bringing a completely new device into the market, then they have to apply with a PMA. If there are already “predicate devices” on the market which are similar to their device, then they can apply with a 510(k).
I would think that CSO could apply with a 510(k) for the Paramax, since there are already corneal topographers on the US market. The FDA’s guidelines say that they will reply to a 510(k) application within 90 days. We first heard that CSO had submitted its application for the Paramax on February 25, so 90 days have now passed.
After the 90 day period, the FDA may ask for “Additional Information”. After they receive this new information from the applicant, they take another 75 days to review it and give another response, but this is only a guideline.
Can anyone tell us if the FDA did respond to CSO with a request for “Additional Information”? I tried to submit this question on the PDMI website, but that page is not working yet. Any information would be appreciated.
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