I've mentioned this before, but will remind those that think it's taking too long: IMGG filed their 510K on June 15, 2007, approximately 2 weeks before CTGI. They are still waiting just as we are. Typical FDA bullscratch!
robwilly: In a letter dated 27 Sept 2007 from U.S. Sec. of Health and Human Services Leavitt to Chairman Kennedy of Senate Committee on Health, Education, Labor, and Pensions, Leavitt writes the following:
However, as Michael Leavitt was quick to remind Kennedy, these are "FDA days" not calendar days. "FDA day" is a day when FDA is actually reviewing the device. A rubbery definiton, to be sure. In 1993, the average approval time for medical devices was 269 days* (q.v.) prompting calls to abolish FDA-approval monopoly and replace it with private party testers such as 100-year old Underwriters Laboratory (UL tests electical devices and certifies safety of same). Even Fed bureaucracies like OSHA defer to UL certification.
As an aside, pre 1976 FDA played no role in approving medical devices for market. They did have authority to pull provably unsafe devices off the market. The disastrous all-plastic Dalkon Shield IUD (causing 110 septic spontaneous abortions and seven deaths) prompted Congress to give FDA authority pursuant to marketing of medical devices.
LTC has been called a "disruptive technology," arguably, another term for "revolutionary improvement of existing platforms." No one would understand this better than FDA. Perhaps, that may be one reason why they would rather go slow here.
News 
Market Data 
Discover 
