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

[Kenneth Marshall]

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