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

Wed Feb 29 10:28:52 CST 2012

Well said.

Scott

On Wed, Feb 29, 2012 at 11:21 AM,  <radbloom at comcast.net> wrote:
>
>
> Interesting questions...
>
>
>
> I guess I would argue that in most cases the purpose of bioassay is for regulatory compliance , i.e., to provide assurance that regulatory limits are not exceeded.  This would be similar to the use of external dosimetry .  In both examples, when regulatory limits are far exceeded, it might be appropriate to suggest medical surveillance/intervention and at that time, further testing might fall into the FDA's purview.  I would also argue that emergency screening is done not to cure, mitigate, treat or prevent disease, but to determine if further evaluation, e.g., a medical evaluation is warranted.
>
>
> Cindy Bloom
>
>
> ----- Original Message -----
>
>
>
>
> From: "Kenneth Marshall" < kenneth . marshall @ carestream .com>
> To: "The International Radiation Protection (Health Physics) Mailing List" < radsafe @health.phys. iit . edu >
> Sent: Wednesday, February 29, 2012 10:43:04 AM
> Subject: Re: [ RadSafe ] Radiation Bio-Assay - Are or Should        Methods        be        FDA        Approved?
>
> 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@ cdc .gov>
> To:     "The International Radiation Protection (Health Physics) Mailing
> List" < radsafe @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@ gmail .com>
> To:     "The International Radiation Protection (Health Physics) Mailing
> List" < radsafe @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 @ 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 @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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