FDA Issues Guidance for New Strategy on Reuse of Single-Use Medical Devices: "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals"
Buchanan Ingersoll & Rooney PC
On August 14, 2000, the Food and Drug Administration ("FDA")'s Center for Devices and Radiological Health issued ".
Frequently Asked Questions About Preemption and Food and Drug Administration's Final Rule on Tobacco
U.S. Dept. of Health and Human Services, Office of the General Counsel
Document prepared by the Food and Drug Administration (FDA) which answers frequently asked questions regarding preemption and the FDA's final rule on tobacco.
Torts Case Law in Texas
Hays, McConn, Rice & Pickering, P.C.
A. NEGLIGENCE: 1. DUTY: a.Van Horn v. Chambers, 970 S.W.2d 542 (Tex., July 3, 1998): The Court h.
Preemptive Defense May Soon Fade in Toxic Shock Syndrome Cases
Tydings & Rosenberg LLP
Toxic Shock Syndrome, (hereinafter "TSS"), a serious and often fatal blood disease, has been linked to the use of m.
Circuits Split Over Federal Preemption of State Claims Against Medical Device Manufacturers
Tydings & Rosenberg LLP
Manufacturers of medical devices suffered a major setback recently when a federal appellate court held that "premar.
FDA to Regulate the Reprocessing of Disposable Medical Devices by Hospitals
Arent Fox LLP
Recently, the Food and Drug Administration issued draft guidelines demonstrating how the agency will regulate hospitals that re-use disposable or single use medical devices.
Users Facilities Requirements Under the Safe Medical Devices Act
Ivan J. Punchatz of Buchanan Ingersoll & Rooney PC
Manufacturers should be aware of their responsibilities and requirements under the Safe Medical Devices Act. They m.
Proposed FDA Regulation Should Be Opposed
This newsletter covers a new rule issued by the Food and Drug Administration regarding the Medical Device Amendments Act of 1976 which would not only expose manufacturers to more lawsuits, it would deny consumers access to some life-saving or life-enhancing products.
Health & Fitness Medical Products--Caveat Emptor & FDA Jurisdiction
Gregg A. Farley and Mark Obenstine of Brobeck Phleger & Harrison LLP
This article discusses the issue of public safety when using quasi-medical devices without the guidance of a medical professional. This article outlines whether the FDA has jurisdiction over such health and fitness products that are marketed directly to consumers or over the internet.
Regulatory Preemption of Medical Devices
Kevin R. Costello and Christopher Q. Pham of Sedgwick, Detert, Moran & Arnold LLP
The FDA has exercised a rigorous pre-market approval process for medical devices since 1976. Yet not all products liability claims involving medical devices are subject to federal regulatory preemption. This article defines the current boundaries between federal and state laws that affect medical devices.
Year 2000 Law Bulletin, March 1999
Bruce F. Mackler of Heller Ehrman LLP
This bulletin provides information about the potential effects of the Y2K problem on medical devices and the health industry.