Calling FCC, FDA. Anybody Home?
By
John Pulley
On paper, it makes sense to combine the might of the Federal Communications Commission and the Food and Drug Administration to "promote innovation and investment in wireless medical devices," as reported here yesterday.
On paper, it makes sense to combine the might of the Federal Communications Commission and the Food and Drug Administration to "promote innovation and investment in wireless medical devices," as reported here yesterday.
In reality, skepticism is in order. After writing yesterday's blog item (but before posting it) the link to a joint statement released by the agencies died. Also rendered inoperable were URLs for a Joint Statement on Wireless Medical Devices and a Memorandum of Understanding released by the agencies.
I was heartened that I didn't have to rely on WikiLeaks for these documents, but come on. What gives? Is the server down? Did the FCC and FDA decide to remove the docs from public view? Multiple calls to FDA's office of public affairs went unanswered. By the time you read this, the agencies may have repaired the problem.
How much confidence should we have in federal agencies to regulate the emerging sector of wireless health devices, given that these agencies haven't yet mastered the art of telephone technology or posting information online?
Perhaps I'm being unkind. After all, no one gets IT right all the time, right? Experience, though, tells me to be wary. I can't tell you how many times, in my experience, an IT web conference sponsored by a federal agency was undermined by a tech glitch. It happens all the time. Either the IT gods have a wicked sense of humor or federal agencies are simply inept in their use of information technology.
If you owned a pasta factory, would you hire an operations manager who can't boil spaghetti?
I was talking the other day with a guy who does IT work for NIH, which lost power during the devastating storm that roared through the Washington, D.C. metro area on Sunday. Getting operations back on line was a challenge, in part because NIH's IT function is carved up into a multitude of fiefdoms, each of which does its own thing. Appeals to consolidate and outsource NIH's IT function to an organization that specializes in such things have fallen on deaf ears, he said.
At least one other person is skeptical of the FDA-FCC partnership. Irene Berlinsky, a senior researcher at International Data Corporation (IDC), has her doubts, reports InformatonWeek:
It remains to be seen how this partnership affects the regulatory burden wireless health devices will bear. The FCC and the FDA collaboration is meant to streamline the review process for new devices. Nonetheless, it is possible that involving two agencies may in some cases slow the time to market for new devices.