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-- 1999 Year End in Review --

As we all prepare for the start of the new year - 2000 - and ponder the effect Y2K will have on our lives, perhaps we can look back at what occurred in 1999 and see if it can provide some insight as to what the start of the next millennium might mean to the industries being regulated by the FDA.

The FDA might call 1999 the year of "conciliation" to its industry. If it's at all possible, it is actually a good time to be an FDA regulated industry. The FDA is working hard to provide the industry with everything they want while still providing some semblance of consumer protection.

Now don't get me wrong, many of these pro-industry "things" are also good for the consumer. The FDA has sped up the 510(k) review process and this is good for both industry and the consumer. The FDA has provided the industry two other alternatives for getting 510(k) clearances - the "Special" and the "Abbreviated" 510(k) although both these methods do have their drawbacks.

The FDA has given the industry the "NEW" warning letter, or as I like to call it the "Non-Warning Letter Warning Letter." This is very pro-industry, allowing the industry to provide the FDA immediate response to FDA 483 and thus precluding the issuance of a Warning Letter, if in fact one was justified. It would appear that in this case no one would be the wiser except for the FDA and the company in question.

The major news in the FDA this year is the new inspection policy, the Quality System Inspection Technique or as the FDA calls it the QSIT. Basically, the FDA is back to where they were prior to 1991, using a top down approach of conducting medical device inspections. This brings the FDA in closer harmony with the European Community who are used to the ISO audits. For whatever reason ISO audits have been using the top down approach for quite some time.

The FDA is still interested in applying the Hazard Analysis Critical Control Points (HACCP) to the medical device industry and it will be interesting to see how this pans out in the new millennium. HACCP is a very interesting approach that could be very beneficial to the industry. Hopefully this will be worked into the QSIT inspectional approach in the near future.

So what do we have so far? An FDA that will work with the industry to avoid adverse publicity. An FDA that has sped up the 510(k) review process. An FDA that is trying to achieve harmonization with the European Community. What can we look for in the new millennium? That remains to be seen. Even I don't have a crystal ball.

However, if one was to look deeply into the future and by some chance the democrats were to gain control of the House of Representatives, there is a good chance that many of these pro-industry initiatives would be slowly set aside and replaced with a much stronger pro-consumer stance.

So, drink up and be merry, for this is the start of something that we have never seen before. A year that begins with a 2.

Hopefully, the Y2K bug will not be one with a big sting but merely a small pest that can easily be shooed away. Hopefully the year 2000 for the medical industry will be as exciting and interesting as the last year of the 20th Century.

See you next year.

Next Month’s Insight Report –

The next Insight Report Vol. 3 #1

Has the FDA lost its Objective?

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