Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule.
(49/1514)
The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). (+info)
Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.
(50/1514)
The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices. (+info)
FDA licensure of NEUMEGA to prevent severe chemotherapy-induced thrombocytopenia.
(51/1514)
This paper discusses background information and the body of clinical data that has been accumulated to demonstrate the efficacy and safety of NEUMEGA (recombinant human interleukin 11) when used to prevent severe chemotherapy-induced thrombocytopenia and reduce the need for platelet transfusions in patients with nonmyeloid malignancies. NEUMEGA is recommended to be used at a dose of 50 microg/kg s.c. once daily starting the day after chemotherapy ends until a platelet count of 50,000 cells/microl is achieved after the expected nadir. (+info)
Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule.
(52/1514)
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices. (+info)
Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule.
(53/1514)
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user. As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol. (+info)
Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule.
(54/1514)
The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness. (+info)
Control of communicable diseases; apprehension and detention of persons with specific diseases; transfer of regulations. Food and Drug Administration and Centers for Disease Control and Prevention, HHS. Final rule.
(55/1514)
The Secretary of Health and Human Service (the Secretary) is transferring a portion of the Food and Drug Administration (FDA) "Control of Communicable Diseases" regulations to the Centers for Disease Control and Prevention (CDC). In general, these regulations provide the Secretary with the authority to apprehend, detain, or conditionally release individuals to prevent the spread of specified communicable diseases. The regulations implement the provisions of the Public Health Service Act (PHS Act) to prevent the introduction, transmission, or spread of communicable diseases from one State or possession into any other State or possession. CDC will have authority for interstate quarantine over persons, while FDA will retain regulatory authority over animals and other products that may transmit or spread communicable diseases. The Secretary is taking this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness. (+info)
Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human). Food and Drug Administration, HHS. Final rule.
(56/1514)
The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives. (+info)