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

Wed Feb 29 09:43:04 CST 2012

John - Agree with your summary. However I am not talking about a drug or 
course of treatment, I am talking about an instrument and/or process that 
screens for the presence uptake of a isotope from a donated sample (e.g. 
excreted sample) 

According to the correspondence given by the federal authority  (see 
below)

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

(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. "

I guess they see screening for radiological contamination in the body 
intended as a method to mitigate or prevent disease and any such devices 
should be FDA approved - That would mean the process including the 
popsicle stick you gather your fecal sample with has to undergo FDA good 
Manufacturing practices - which drives the cost up significantly as well 
as the time to market, etc. 

I guess, if Its an issue that has been riding between the lines of 
interpretation, there is no further point to stirring up trouble - it was 
a fact finding mission to determine what the boundary line was and If I 
could find examples of either side of the issue. 

Thanks,

Ken Marshall
Carestream Heath 
Radiation Safety Officer
585-627-8523

All,

If ascertaining an occupational dose to a person, the cognizant authority 
(for an employee) would be the employer (NRC, DOE, utility, hospital, 
etc.). Assignment of dose should be done by a competent authority. A dose 
determination using bio-assay samples for humans cannot be equated to 
regulation of a drug. Bio-assay samples are not drugs. I do not believe 
that the FDA has purview over what is being discussed here (i. e. the 
specific test to determine the radionuclide intake).

If a course of treatment is chosen, and if that treatment involves using 
an FDA approved compound, then the use of such a compound should (not 
must) be approved by the FDA. There are many courses of treatment which 
have been proven effective (but not necessarily for human use) and these 
compounds have yet to be FDA approved. 

Given what could occur during a response to a radiological incident, 
decorporation using a safe compound is best left to the attending 
physician.

Regards,

John E. Dixon

From:   "Dixon, John E. (CDC/ONDIEH/NCEH)" <gyf7 at cdc.gov>
To:     "The International Radiation Protection (Health Physics) Mailing 
List" <radsafe at health.phys.iit.edu>
Date:   02/29/2012 09:58 AM
Subject:        Re: [ RadSafe ] Radiation Bio-Assay - Are or Should 
Methods be      FDA     Approved?
Sent by:        radsafe-bounces at health.phys.iit.edu

All,

If ascertaining an occupational dose to a person, the cognizant authority 
(for an employee) would be the employer (NRC, DOE, utility, hospital, 
etc.). Assignment of dose should be done by a competent authority. A dose 
determination using bio-assay samples for humans cannot be equated to 
regulation of a drug. Bio-assay samples are not drugs. I do not believe 
that the FDA has purview over what is being discussed here (i. e. the 
specific test to determine the radionuclide intake).

If a course of treatment is chosen, and if that treatment involves using 
an FDA approved compound, then the use of such a compound should (not 
must) be approved by the FDA. There are many courses of treatment which 
have been proven effective (but not necessarily for human use) and these 
compounds have yet to be FDA approved. 

Given what could occur during a response to a radiological incident, 
decorporation using a safe compound is best left to the attending 
physician.

Regards,

John E. Dixon

-----Original Message-----
From: radsafe-bounces at health.phys.iit.edu [
mailto:radsafe-bounces at health.phys.iit.edu] On Behalf Of Kenneth Marshall
Sent: Monday, February 27, 2012 6:56 AM
To: The International Radiation Protection (Health Physics) Mailing List
Subject: Re: [ RadSafe ] Radiation Bio-Assay - Are or Should Methods be 
FDA Approved?

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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