Zdrowie i gospodarka · 21.07.2011
Standard Operating Procedure for “Notice to Industry” Letters
The Food and Drug Administration (FDA) is announcing the availability of the standard operating procedure (SOP) for "Notice to Industry" Letters. The SOP describes the Center for Devices and Radiological Health's (CDRH) process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect, data submitted as part of an Investigational Device Exemption (IDE) or premarket submission that needs to be disseminated in a timely manner.