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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
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 Subject :US FDA new rule on reporting information regarding falsification of d.. 2010-02-26 04:47:33 
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Subject :US FDA new rule on reporting information regarding falsification of data

Dear Friends,

The Food and Drug Administration is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigators, nonclinical laboratory studies, and clinical studies in animals.

The proposed rule is now available using the following web link: http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf.

Comments to this proposed rule are due by May 20, 2010.

Kind regards,
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