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Year in Review - 1998

Well, I could say "What a year 1998 was for the medical device industry" or, "1998 was a great year for Insight." Perhaps "1999 could be a very interesting year for the FDA.," is the way to say it.

They all sound very plausible and have a sense of reality.

1998 was a very interesting year for the medical device industry. With the FDA modernization act in full force, the FDA trying hard to figure how deal with a shrinking budget and trying to live up to their obligation of the MRA with the European Community.

Let's look at some of the developments during 1998 that have effected the medical device industry:

FDAMA - Design Review becomes enforced - New inspectional approaches HACCP and the QSIT are put into trials - The third party 510(k) review is renewed with more devices added to the list - The MRA with the European Community may include third party inspections of medical device companies - New Warning Letter initiatives - More medical devices are removed from 510(k) requirements - There is a real possibility that Consumer protection has been made into a lower priority.

The FDA regulatory pendulum has been known to swing back and forth between a strong regulatory policy and a policy of capitulation with the industry. If you are not sure which mode the FDA is now in, it is not one of strong regulatory policy.

A looming questin is: With the ongoing Congressional budget cutting and the mandating of the FDA to work closer with industry (to bring more products to market faster with less regulatory review as well as allow foreign countries to conduct third party FDA GMP inspections), will the FDA be able to continue to provide the U.S. consumer the protection they are depending on with these present positions.

The last time the FDA took such a liberal stand on industry was in the late 1980 and that resulted in the Generic Drug Scandal and we all know what the results of that period in history had on the device industry.

So what should the device industry look for in 1999? There are several things on the horizon that could shape the industry.

A new FDA commissioner. - Y2K situation - The battle between the HACCP and QSIT inspectional approachs - How will the public and the industry look at the third party GMP inspections? - The new Warning Letter approach

Should the industry continue to look at the FDA as a partner or be just a little weary? You all know how the saying goes, "If it looks like a duck and walks like a duck and quacks like a duck...."

Just be careful out there and enjoy these good times. The FDA pendulum will swing again. That you could be assured of. Hopefully, the next change in the FDA regulatory policies will not be as a result of consumer safety issue.

Have a happy New Year and I hope you continue to visit mdi's Insight on our Website.

See you in 1999.

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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