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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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 Subject :FDA's proposed rule on Post-marketing Safety Reporting for Combination.. 2010-01-12 20:15:13 
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Subject :FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts

Dear Friends,

Closing date for the comments on the FDA's proposed rule on Post-marketing Safety Reporting for Combination Products is January 29, 2010 and seeking comments on its proposed rule to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products.  The proposed rule is intended to clarify the reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product.

Click here for the proposed rule.

Kind regards,
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