Department of Health and Human Services February 8, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not include medical device data systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be exempt from the premarket notification requirements when it is indicated for use only by a healthcare professional and does not perform irreversible data compression.

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing colchicine for injection (hereinafter ``colchicine for injection products''), and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce. All colchicine for injection products are administered intravenously. Colchicine is associated with a variety of serious adverse events, some of them potentially fatal. Furthermore, a narrow margin of safety exists between a therapeutic dose of colchicine and a toxic dose of the drug. Colchicine for injection products are new drugs that require approved applications because they are not generally recognized as safe and effective. Manufacturers who wish to market a colchicine for injection product must obtain FDA approval of a new drug application (NDA).