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Compliance In Focus
Posted by John Lehmann on Mon, Apr 2, 2012

21 CFR 812.20: Was Enough Information Provided to the FDA?

In a recent news-release it was stated that Kips Bay Medical, Inc. will once again seekInformation approval to carry out device trials of their investigational product in the US. Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application (21 CFR 812.20) to the FDA.

According to 21 CFR 812.30, the FDA actions on IDE application include:

  • Approval of an investigation as proposed
  • Approval with modifications
  • Disapproval

Last September, the FDA advised Kips Bay that they provided insufficient data to support the request for an investigational device exemption (IDE) for their product. The company hoped to bring the eSVS Mesh product into the US clinical trial arena.

The company already completed a 90-patient international clinical trial earlier in 2011, and launched an initial public offering of 2.1 million shares to raise proceeds for developing and getting regulatory approval for its device. Interestingly, shares of Kips Bay Medical were down by nearly 30% after the announcement in late 2011.

So, what’s different this time?

The company announced that they have gathered the necessary information “in order to address questions raised by the FDA. The data includes clinical results from a study through which patients were implanted with eSVS Mesh devices at the American Hospital in Dubai, United Arab Emirates.”

It will be interesting to see how the second attempt plays out for Kips Bay, in both the market and FDA’s responses. Do you think a second time is a charm? Comment below and tell us what you think!

 Photo Credit: heathbrandon

Topics: Kips Bay Medical, FDA


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