[ RadSafe ] Radiation Bio-Assay - Are or Should Methods be FDA Approved?

[Kenneth Marshall]

Chris 

For either clinical or occupational and I can see where some occupational 
methods (like bio-assay) are used to determine treatment is needed.  - 

My understanding of the  interpretation from the representative implied 
that regardless of clinical or occupational in use - If it is used to 
determine a course of treatment of any kind,  then it would need be FDA 
approved - regardless of setting. 

Lets say for example - when one provides an excrement or urine sample to 
determine exposure on the job - and that sample determines that an 
individual had an intake that requires any treatment (e.g. purging with 
water, chelates or even washing hands) then the corresponding analysis 
method would need to be FDA approved is my understanding from 
correspondence.  I'm just not that certain that this has been the case 
with bio-assay techniques - And if not, then why?

I can see a line between methods that measure the work "environment" then 
the e.g. Industrial Hygiene where one takes action to change behaviors on 
the job, not necessarily treatment. - But it seems the rules would change 
whenever those methods are actually utilized (even potentially so) in the 
course of treatment. 

I'm not trying to poke the lion with a stick on this issue, just a little 
confused where the line gets drawn and if such tests like bioassay 
were/are  FDA approved.

Thank you.

-Ken

Ken Marshall
Carestream Health Radiation Safety
585-627-8523




From:   Chris Alston <achris1999 at gmail.com>
To:     "The International Radiation Protection (Health Physics) Mailing 
List" <radsafe at health.phys.iit.edu>
Date:   02/25/2012 05:56 PM
Subject:        Re: [ RadSafe ] Radiation Bio-Assay - Are or Should 
Methods be FDA  Approved?
Sent by:        radsafe-bounces at health.phys.iit.edu



Ken

Are you asking in re bioassays in the arena of occupational health or
clinical medicine?

Cheers
cja


---------- Forwarded message ----------
From: Kenneth Marshall <kenneth.marshall at carestream.com>
Date: Wed, Feb 22, 2012 at 1:27 PM
Subject: [ RadSafe ] Radiation Bio-Assay - Are or Should Methods be
FDA Approved?
To: "The International Radiation Protection (Health Physics) Mailing
List" <radsafe at health.phys.iit.edu>


OK I'm running around this question and I don't deal with Bio-Assay
frequently - but do Bioassay methods require FDA approval?

Why or Why not?

I can see where external  occupational dosimetry (for radiation and other
agents)  measuring the work "environment" and not clinical  as rationale
for not being FDA approved.

I spoke to an FDA employee/contractor that gave me the impression that
Bioassay techniques need to be FDA approved under condition 2 below:

Section 201(h) for the Federal Food, Drug and Cosmetic Act define as:

an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any
component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States
Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or "other conditions" ,
or in the cure, mitigation, treatment, or prevention of disease, in man or
other animals, or

(3) intended to affect the structure or any function of the body of man or
other animals, and which does not achieve its primary intended purposes
through chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of its
primary intended purposes.

If the testing information is to be used for diagnosing a disease or
condition in a person or animal then it would be considered a medical
device.

The FDA guidance on the overview of medical device regulations will help
provide you with detailed information on the FDA regulatory process.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm


I don't recall Bio-assay tests being FDA approved, but I'm not savvy
enough on the subject of bio-assay to know if they were are or are not and
why so.

Any help on or off Radsafe would be deeply appreciated.

-Ken

Ken Marshall
Radiation Safety Officer
Carestream Health
Rochester, NY

Phone 585-6278523




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