Federal Register Notice: FDA is correcting inadvertent errors in a 1/5 Federal Register notice that provided the agency's annual comprehensive list of guidance documents. On page 867, in the list, under the heading “Guidance Documents Issued by CDRH — Continued,” the entire entry is removed for the document entitled “Review of 510(k)s for Computer Controlled Medical Devices (blue book memo K91-1)” and for the document entitled “FDA Policy for The Regulation of Computer Products; Draft.” These two guidance documents were listed in error as both current and withdrawn. These guidances have been withdrawn. And on page 894, in the list, under the heading “Guidance Documents Issued by CFSAN,” the entire entry is removed for the document entitled “Investigations Operations Manual” and for the document entitled “Regulatory Procedures Manual.” These two guidance documents were listed as being issued by CFSAN in error. They can be found in the list of guidance documents issued by the Office of Regulatory Affairs. To view this notice, click here.
