SpectrumTalk

FDA Asks National Academies to Review Its Approval Process
for New Technologies:
Why Doesn't FCC Ever Do This?

I have previously discussed the June 5, 2008 IEEE-USA letter to Chairman Martin (that never was answered in any way) that suggested improvements to FCC technical policy deliberations.

Part of the letter said,

• The National Academies. In the past FCC, like other federal regulatory agencies with technical jurisdiction, sought advice on long-term policy issues from the National Academies including the National Academy of Sciences and the National Academy of Engineering.

However, the last time the FCC asked for studies from the National Academies was in the 1970s when such studies laid the groundwork for two major changes in technical policy: the Part 68 interconnection rules and the sharing of the C band between terrestrial and satellite systems. Both of these issues were tremendously controversial at the time but the basic frameworks suggested by these studies formed the basis for major changes in FCC policy.

Such studies are time consuming and expensive and should not be used for routine policy deliberations, but it is clear that in the 30 years since FCC last used such studies there have been multiple cases where they could have been of value. It is not clear why FCC practice differs from other regulatory agencies in the use of the Academies.

To show that real federal regulatory agencies do exactly this type of thing even in this day and age, here is some recent news from FDA which has gotten "egg on its face" for some recent approvals of medical devices.

An FDA news release of 9/23/09 starts,

FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices

The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.

The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.” (Emphasis added)

The Institute of Medicine is the medical counterpart of the National Academy of Engineering, a member of the National Academy family. The press release goes on to say how FDA has asked the IOM to perform a $1.3 million 2 year study to review its processes and make recommendations. The study will include 2 public workshops.

Perhaps FCC deliberations for approval of new spectrum technologies merits the same type of objective review?

N.Y. Times article on this issue