The issue of FDA days and non-FDA days in device applications has been one of the sticking points in the current round of user fee negotiations, and the agency's meeting minutes from the Aug. 24 meeting indicate that FDA may be willing to flex on this point. For those who are concerned about the prospects of cobbling together a user fee agreement to present to Congress by January, the development is an important one as it removes a major hurdle, although several remain. (Medical Device Daily)

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...