[ RadSafe ] FDA approval of bioassay methods

[Kenneth Marshall]

Clayton - Thanks for your comment - I'm still looking for some lines of 
definitions. 

For example some are developing EPR and other tools  for rapid screening 
of population following an emergency event.  If I understand correctly, 
such devices should be manufactured and employed as a "medical device" as 
they screena patient for possible treatment - even screening would be a 
medical device.  Clearly when you manufacture to such standards there is a 
different & significant cost structure and changes a buisness case 
significantly, so I am very interested to learn where the line gets drawn.

Intersting enough, I cannot find, any previously submitted FDA 510Ks or 
medical device applications for biodosimetry devices, methods, 
apparatuses, equipment etc. which leads me to believe it hasn't been 
routinely done.

If someone develops a device to rapidly screen an exfoliated or excreted 
tissue and measure it for the presence of radiation for health related 
concerns & possible (yes possible - meaning screening for elimination of 
treatment)  - it would seemingly be a medical device(s) and need to meet 
FDA approvals - Unless someone can tell me exactly otherwise how it isn't.

Thanks for any thoughts & info you can provide.


Ken Marshall
Radiation Safety Officer
Carestream Health
Rochester, NY 14615
585-627-8523





From:   Clayton J Bradt <CJB01 at health.state.ny.us>
To:     radsafe at health.phys.iit.edu
Date:   02/28/2012 01:12 PM
Subject:        Re: [ RadSafe ] FDA approval of bioassay methods
Sent by:        radsafe-bounces at health.phys.iit.edu



This is an interesting question. Does anyone know whether say, REAC/TS 
employs FDA approved bioassay methods when diagnosing and treating 
radiation injuries? In an emergent situation, as all radiation incidents 
are, do the FDA requirements apply?

Clayton J. Bradt
Principal Radiophysicist
NYS Dept. of Health
Biggs Laboratory, Room D486A
Empire State Plaza
Albany, NY 12201-0509

518-474-1993
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