Grapefruit USA Inc (GPFT)

[ChesapeakePaddler]

Three interesting articles that MAY apply to I3 are condensed in today's FDA Device Daily Bulletin:

Industry: FDA Clearing Fewer 510(k)s to Meet User Fee Goals
The percent of 510(k) applications that FDA finds “not substantially equivalent” (NSE) has doubled in the past year — from 4 percent of applications in fiscal 2009, to 8 percent in fiscal 2010 — and devicemakers say the agency is using its discretion in issuing NSEs in an attempt to meet user fee review goals. An internal FDA inquiry found the substantial equivalence (SE) rate has been on the decline for the past four years, the agency told industry representatives during a March 7 meeting to negotiate the next reauthorization of the Medical Device User Fee Modernization Act (MDUFMA).
Devices & Diagnostics Letter

U.S. FDA Proposes Fast-Track Pathway Despite Earlier Skepticism
One of the U.S. Food and Drug Administration’s (FDA) departments is creating a new pathway to expedite approval of the most innovative devices — an about-face from its reaction to a similar proposal. The new initiative, dubbed the “innovation pathway,” is the core component of a multi-pronged program to minimize delays that can occur when pioneering devices raise novel and challenging scientific questions. The FDA’s Center for Devices and Radiological Health (CDRH) proposes a review time frame of 150 days, approximately half the time it takes to review most premarket approval applications (PMAs).
International Medical Device Regulatory Monitor

IOM Seeks Medical Device Industry Advice on 510(k)
The Institute of Medicine (IOM) has completed its review of the FDA’s 510(k) clearance protocol and is seeking input from the medical device industry about its findings. Adding some med-tech voices to the panel could help quell persistent complaints that the medical device industry has been woefully under-represented in the FDA’s 510(k) reform process. The IOM’s independent review is part of FDA’s push to revamp the protocol by which the vast majority of medical devices are cleared for market in the U.S.