Department of Health and Human Services July 11, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatDrug Establishment Registration and Drug Listing.'' This draft guidance document establishes a Pilot Program for industry to voluntarily submit drug establishment registration and drug listing information in an electronic format that FDA can process, review, and archive. The document provides guidance on what required and FDA-recommended information related to drug establishment registration and drug listing to submit and on how to electronically prepare and submit the information to FDA.

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves.'' This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of surgeons' and patient examination gloves (medical gloves) from manufacturers/shippers whose medical gloves have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that medical gloves imported to the United States meet FDA's minimum acceptable quality criteria and do not have defects that could compromise their effectiveness and pose a health hazard to healthcare professionals and patients who rely on medical gloves for protection from blood- and fluid-borne pathogens.