Who Regulates the Regulator?
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA has very broad responsibilities for assuring the safety of foods, drugs, medical devices, biologicals, and veterinary products. In the whole range of medical devices, the FDA's Center for Devices and Radiological Health enforces a complex set of regulations applicable to the manufacturers of medical devices and others, for example, researchers who are evaluating medical devices for their safety and efficacy.
The FDA has police powers: they can inspect facilities, examine records, investigate complaints about devices, and more. They have a range of enforcement tools ranging from warning letters to seizing products to criminal prosecutions.
The question is: who regulates the regulator? Relying heavily on the writings of a former FDA General Counsel, we will address that issue at a later date.
Towards a Rational Approach to Regulation
It is important to recognize that much as pharmaceuticals may have unintended adverse effects, regulation may also have unintended adverse side-effects. I will discuss this issue by means of a simplified model which everyone should be able to understand.
Justification for the Medical Device Law
Later, I will discuss the arguments set forth to justify the broadened authority for the FDA granted by the Medical Device Amendments. Particular attention will be given to some original research into the death and injury statistics which were put forth by the government and widely quoted. In addition, two "problem" devices cited by the FDA will be discussed.
Impact on Innovation
One of the unintended adverse side-effects of regulation may be useful devices which never make it to market or whose entry into the market are delayed by onerous regulations or bureaucratic delays.
Evolution of PreMarket Notification
What is PreMarket Notification? A premarket notification is a document submitted to the Center for Devices and Radiological Health (CDRH) by a company that intends to market a new or changed medical device. Another name for a premarket notification is a 510(k) notification, or 510(k) notice because this procedure is defined in section 510(k) of the Medical Device Amendments.
The details of the process are still evolving more than 30 years after the enactment of the Medical Device Amendments on May 28, 1976. In fact, CDRH sponsored a public meeting on February 18, 2010, to solicit comments from industry, consumer groups and the public. I was one of the people permitted to address the gathering of nearly 400 people at the meeting. The meeting was webcast, enabling anyone with access to the internet to see and hear the proceedings.
The webcast is still available at an archive. To see any part of the meeting, go to
There you will see three files. To see my presentation on the subject of "predicate creep" click on Part 2. My talk begins 50 minutes into the file. You should be able to use the scroll bar on whatever viewer you use to get there quickly.
The essence of my presentation was that the FDA had cleared as "substantially equivalent" a short series of devices in a subset of shortwave diathermy. The original "predicate" device has a peak power of 975 watts; subsequent devices have peak powers of 400 watts, 10 watts, 2.5 watts and 0.043 watt! Despite orders of magnitude difference in power, FDA decided these devices are substantially equivalent!
A study of the 510(k) process by the Institute of Medicine concluded in 2011 that the process is so flawed, it should be scrapped entirely!
Why You Should Care
The FDA has enormous power over the medical device industry. In my opinion, the FDA requirements are so demanding as to drive business away from the U.S. making useful devices unavailable to the Americans.