[ RadSafe ] Radiation Bio-Assay - Are or Should Methods be FDA Approved?
kenneth.marshall at carestream.com
Wed Feb 22 12:27:08 CST 2012
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
The FDA guidance on the overview of medical device regulations will help
provide you with detailed information on the FDA regulatory process.
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
Any help on or off Radsafe would be deeply appreciated.
Radiation Safety Officer
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