Just thought you'd all be interested in this info. Thanks to Bryan Kiehl
for the insight.
>Return-Path: <owner-biz-biotech at netcom.com>
>Date: Wed, 10 May 1995 11:29:49 -0700
>To: jhughes at postbox.acs.ohio-state.edu (jhughes)
>From: b3748 at cts.com (Bryan Kiehl)
>Subject: Re: FDA Classification of antibodies
>Cc: biz-biotech at netcom.com>Sender: owner-biz-biotech at netcom.com>Precedence: list
>>> Do you have any information about the FDA consideration to classify
>>antibodies as Class II medical devices? Where is a good place to acquire
>>information about Class I, II, III etc. medical devices? Any details you
>>can provide would be greatly appreciated.
>>>The classifications your mention are not for antibodies or chemical, but for
>products distributed in the US. If the product is intended for clinical
>uses, then the FDA is required to review claims of the product and assure
>that it is "safe and effective" as claimed. There are three classes of
>medical devices (devices include in vitro diagnostics). Class III is given
>to products that have great affects on patients or patient management while
>class I includes products with the least concern (e.g., throat swabs,
>collection tubes, etc.). Recently, these classifications have been under
>review and probably, at least for class I and II, don't have alot to do with
>how a product is judged by the FDA.
>>The laws providing this information are described in CFR's. How these are
>interpreted are a matter of much debate and review. The antibodies the FDA
>seems to be most concerned about are things like anti-CEA, AFP, and other
>cancer markers. However, the law does not allow them to pick only some
>reagents that are clinically used.
>>I work in a diagnostic company that buys antibodies and puts them into kits.
>Since we test these antibodies (quality assure) before using them in FDA
>cleared kits, this is acceptable and the manufacturer of the antibody
>doesn't need to be concerned. The problem arises when the original antibody
>manufacturer sells these reagents to someone who uses them clinically
>without qualifying them. The next obvious question is does testing (quality
>assurance) in a laboratory qualify. The problem arises that no one reviews
>the quality assurance testing done for this reagent by the laboratory. This
>type of testing is not reviewed or understood by CLIA, the agency given the
>mission to oversee labs. FDA has stated that they believe the FDA has the
>authority and responsibility to oversee this.
>>That's the problem. We all await the solution(s).
>>Hope this helps. Please understand that much of the above is opinion. There
>seems to be little in the way of facts.
cliu at ic.net
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