CDRH "docket"
This article was originally published in The Gray Sheet
Executive Summary
Center for Devices and Radiological Health's division of small manufacturers assistance establishes public document repository at FDA headquarters at 12420 Parklawn Drive in Rockville, Maryland, the agency announces July 22. The docket contains guidance documents, proposed and final regs, major speeches by CDRH and agency topsiders, and periodic publications. FDA announced plans for the docket earlier this year ("The Gray Sheet" March 1, I&W-1). An electronic version of the docket, which will provide access to the same information via computer modem, should be operational by October 31, FDA says. The electronic docket access number will be 301/594-4802; a toll-free number may be provided in the future.