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FDA released final guidance documents on what constitutes a significant change

shimonv

shimonv

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mihzago

mihzago

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Gotta love some of the language used in the guidance. For example:

"A change intended to significantly affect the safety or effectiveness of the device is considered to be a change that “could significantly affect the safety or effectiveness of the device” and thus requires submission of a new 510(k) regardless of the considerations outlined below."
 
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