From owner-diagnostics@net.bio.net Wed May 10 23:00:00 1995 Path: biosci!IC.NET!cliu From: cliu@IC.NET (Christina Liu) Newsgroups: bionet.diagnostics Subject: Re: FDA Classification of antibodies Date: 11 May 1995 16:00:55 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 59 Sender: daemon@net.bio.net Distribution: world Message-ID: NNTP-Posting-Host: net.bio.net Just thought you'd all be interested in this info. Thanks to Bryan Kiehl for the insight. >Return-Path: >Date: Wed, 10 May 1995 11:29:49 -0700 >To: jhughes@postbox.acs.ohio-state.edu (jhughes) >From: b3748@cts.com (Bryan Kiehl) >Subject: Re: FDA Classification of antibodies >Cc: biz-biotech@netcom.com >Sender: owner-biz-biotech@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@ic.net Internet connectivity provided by ICNET: +1 (313)998-0090 .