I am reminded of another "deliverable" that remains missing. On July 16, 2009, FDA cleared a 510(k) premarket notification (actually a de novo submission) for Vermillion's OVA1 Test (Intended use: The OVA1™ Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Although clearance was granted in July, the detaill were not posted to the FDA website until about a month later (that seems about normal) and the FDA press release about the clearance was issued September 11, 2009 (nearly 3 months later - is that normal?).
Like many of you, I have been under the impression (apparently mistakenly) that part of the process for clearing a de novo 510(k) was the development of a Special Controls guidance document. The Special Controls guidance document was identified in the FDA clearance letter for the Vermillion assay (http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081754.pdf). To date, FDA still has not issued the guidance. When contacted several months ago, the story was that it was "difficult" to issue guidance. I must concur. It seems extremely difficult since now 18 months have passed since the 510(k) was cleared and FDA has not been able to issue a guidance document that should have been completed at the time the 510(k) was cleared.
Today it is Groundhog Day and I suspect we will see a good deal of time, say six more weeks of waiting (apologies to the groundhog) until we see the promised framework. I'm not holding my breath for the MIA guidance document.
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