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

Wed Feb 29 16:03:03 CST 2012

John et al. --

Perhaps a better way to phrase this is, does a laboratory that analyzes bioassay samples have to be CLIA (Clinical Laboratory Improvements Amendments) certified? If memory serves, this very issue was discussed at length at one of the recent CDC roundtable meetings.

The language on FDA webpages (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm, for example) seems to indicate that such laboratories should be certified ... "A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health."

I'm not entirely certain ... even after our earlier lengthy discussion.

Jim Hardeman 

>>> "Dixon, John E. (CDC/ONDIEH/NCEH)" <gyf7 at cdc.gov> 2/29/2012 09:56 >>>
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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