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At least 181 records · Page 10Linked to original sources
PubMed1996

FDA regulation of medical devices. FDA perspective.

In this article, based on a presentation before The Society of Thoracic Surgeons, D. Bruce Burlington, MD, director of the United States Food and Drug Administration's Center for Devices and Radiological Health, describes the role of the Center in regulating medical devices. Doctor Burlington discusses issues concerning investigational device exemptions and development of protocols, marketing review for new products, the use of guidance by the agency in developing products, and humanitarian device provisions. He focuses this discussion on circulatory support devices and therapies for cardiac patients. Throughout the discussion, Dr Burlington encourages manufacturers of new devices to discuss their plans and protocols with the agency before beginning their studies.

Device Approval↗
PubMed1998

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.

Decision Making, Organizational↗
PubMed1998

Medical devices; neurological devices; classification of cranial orthosis--FDA. Final rule.

The Food and Drug Administration (FDA) is classifying the cranial orthosis into class II (special controls). The special controls that will apply to the cranial orthosis are restriction to prescription use, biocompatibility testing, and certain labeling requirements. The agency is taking this action in response to a petition submitted under the Federal, Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying cranial orthosis into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Device Approval↗
PubMed1997

Anesthetic implications for implantation of a left ventricular assist device: a case study.

A left ventricular assist device (LVAD) is intended for use as a temporary bridge to transplantation in patients with end-stage cardiac failure until a donor heart becomes available. This case report discusses the anesthetic management of a patient undergoing implantation of an LVAD. Tremendous advances have been made in cardiac transplantation; however, there is an acute donor shortage in the face of an increased need for donor hearts. These two factors have been the impetus for the development and testing of a mechanical assist device. A new U.S. Food and Drug Administration approved assist device, the Thermo-Cardiosystems, Inc. (Woburn, Massachusetts) implantable pneumatic LVAD is proving to be very successful as a bridge to transplantation. A case is presented of a 40-year-old male with debilitating cardiomyopathy in conjunction with mitral regurgitation, pulmonary hypertension, and mild tricuspid regurgitation. He had reached the point of multisystem organ failure which had left him incapacitated while awaiting cardiac transplantation.

Adult↗
PubMed1991

Electrical stimulation for dermal wound healing.

The investigations of biologic actions (in vitro, animal, and human) demonstrated several effects that help explain why electrical stimulation works. Based on the latest scientific understanding of the wound healing process, one would expect that a therapy that decreases edema, debrides necrotic tissue, attracts neutrophils and macrophages, stimulates receptor sites for growth factors, stimulates growth of fibroblasts and granulation tissue, increases blood flow, stimulates neurite growth, induces epidermal cell migration, prevents postischemic oxygen radical-mediated damage, inhibits bacteria, and reduces numbers of mast cells ought to be beneficial for wound healing. Numerous human and animal efficacy studies confirm that electrical stimulation of the proper charge, density, and total energy causes dramatically improved healing of dermal wounds. As of this writing, no devices have yet been approved by the FDA for use in wound healing, although several devices approved for other indications are being used for this purpose. One device (the Staodyn Dermapulse) has undergone controlled animal and human testing, and an application requesting approval for treating dermal ulcers has been submitted to FDA. Taken together, the efficacy studies and the "mechanism of action" studies provide compelling, scientific evidence that electrical stimulation is safe and effective for promoting the healing of dermal wounds.

Animals↗