The recent Institute of Medicine (I of M) report brings an old idiom to life: “Don’t throw the Baby out with the Bath Water!” According to the IOM, “...The current process is untenable.”  I applaud that Dr. Jeff Shuren, Director, CDRH, FDA, has announced his support for the current 510(k) regulations to demonstrate “substantial equivalence” to a device on the market.

"If it ain't broke, don't fix it," is how I look at the 510(k) regulations. Is there room for improvement?  Yes. I have been bringing new 510(k) products to market since 1982, so I feel a responsibility to speak up.

The chief complaint I see with 510(k) devices is: “How risky devices such as hip implants could be allowed into market without human testing to prove safety and effectiveness, or why devices such as malfunctioning infusion pumps are allowed that put people’s life in danger?” These seem reasonable complaints to me.

There have been more than 46,490 510(k) devices “cleared” by the FDA since 1998 to May, 2010.  A study by Battelle Memorial Institute, September 2010, reported that 0.16%, or 1.6 per 1000, of such devices had Class I (most serious) recalls.  On the whole, devices cleared with 510(k) process have had a very good safety record.

Let’s look at the 510(k) clinical data requirement

Currently, about 10% of the 510(k) submissions require clinical data for low-moderate risk devices.  Typically, 30 or so patients are required to participate.  It is my opinion, such testing might only uncover a major safety or effectiveness concern, if any, yet it is unlikely to uncover smaller risk that might be 0.1% or even 1%.
Smaller percentages such as 0.1% may not show up unless one tests 3000 patients. Besides, evaluating effectiveness becomes tricky; problems may not show-up until years later. 

My conjecture is for devices, such as selected implant applications, might require clinical data to support a 510(k). On the other hand, hopefully FDA will not bump these devices to go the Premarket Approval (PMA) route which usually takes many more years and potentially adds millions of dollars to introduce the product in the USA. Most small start-ups that make up over 80% of medtech companies in the USA (Dr. Makeover report, Stanford University, November 2010) are likely to give up if the device requires a PMA.

Yes, public health is important.  Question is whether perceived safety concerns justify keeping new products/technologies from American Public?
       
Jack Dhuwalia
© 2011