Bryan Kiehl b3748 at cts.com
Mon Jul 1 23:53:08 EST 1996

It is my understanding that the FDA does now require that reagents
that may be used for diagnostic uses (e.g., cancer markers, infectious
disease detection, etc.) are to be regulated.

However, it also appears the amount of regulation is minimal. They
require that the manufacturer follow good manufacturing practices.
These include proper labeling and documentation during the
manufacturing processes, as well as being able to field customer
complaints and document how you deal with these. The regs also require
that the company submit a notifcation with proposed labeling before
marketing the product. This is then reviewed by the FDA for truth and

For example, is the reagent is an antibody, then one must identify
what the antibody recognizes and be sure that all claims are accurate.
If this is only a reagent and not a kit, there can be no performance
claims. These reagents are intended for the user to establish the
assay method. The user (e.g., pathologist, laboratory) must "validate"
that the assay using this reagent performs well enough for diagnostic
uses. The end user must also assure continued performance.

If the manufacturer puts the reagent into kits or claims diagnostic
performance, then he needs to provide data to the FDA. Otherwise, he
mostly needs to just assure that the reagents are made well and
packaged without error.

For most smaller companies this may seem a burden at first, but
similar regs are being established in Europe under ISO regs.

Anyone else interpret this differently? To me, it doesn't look too
bad. I also doubt that true research reagents that are never or rarely
used in the clniical realm will ever be regulated. Remember, the FDA
can only come down on a company that sells these reagents to groups
that really do use them for human diagnostics.
James Stiehr <jstiehr at bioreagents.com> wrote:

>The FDA has just proposed new regulations on the sale and distributions 
>of antibodies and other reagents which will result in the withdrawal of 
>many research reagents from the US market.  The net result of these 
>regulations is the reduction of tools available to the US research 
>community (non-US researchers will still have access to these tools).

>The “Research Use Only” disclaimer WILL NOT prevent the FDA from removing 
>many reagents from the market if suppliers do not treat antibodies as In 
>Vitro Diagnostic Devices, submitting them to FDA for review, approval and 

>For a more thorough review of the issue as well as the regulations 
>themselves, a special web page has been set up as an educational 
>resource.  Visit http://www.earthnet.net/~affinity/fda for an overview of 
>the issues, the proposed regs, and what you can do about them.

>Protect your access to these critically important research tools!  Act 

>James Stiehr
>Affinity Bioreagents, Inc.

Bryan Kiehl
GenBio at msn.com
San Diego, CA

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