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At least 1,315 records · Page 73Linked to original sources
PubMed1996

The nightmare of FDA clearance/approval to market: perception or reality?

Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.

Device Approval↗
PubMed1996

Medical and dental technology assessment.

Spiraling costs dictate that healthcare expenditures be limited to medical products and services of demonstrated safety and effectiveness, if quality care is to be provided at affordable cost. Scientifically conducted, randomized controlled trials are essential elements of this process. Applicable governmental regulatory procedures are reviewed. These serve as the foundation of the technology assessment process and should not be restricted or curtailed. Healthcare provider groups may make significant contributions in this area, when scientific investigation and objective research are emphasized. Technology manufacturers must promote and support objective analysis of their products. Healthcare insurers are assuming greater responsibility and involvement in outcomes research and technology assessment. The process by which this is accomplished by a major insurer is described. Private insurers and governmental agencies should share data in a consolidated research effort. This will require data base adjustments for compatibility and comparability in inter-agency analysis. Insurance company data bases are significant public health assets that have yet to be utilized to the fullest extent.

American Dental Association↗
PubMed1997

Food and Drug Administration regulation of spinal implant fixation devices.

The role of the Food and Drug Administration in regulating medical devices generally is not well understood by physicians. The practice of medicine does not fall under Food and Drug Administrations's regulatory purview. Nevertheless, the Food and Drug Administration and its regulation of medical devices can influence physicians' activities. This article provides an overview of the scope of the Food and Drug Administration's authority and the agency's regulatory framework, with particular focus on orthopaedic medical devices as related to spinal implant devices. During the past 10 years, a regulatory dilemma has arisen surrounding the use of bone screws in the pedicles of the spine. Except for recent clearances for a limited treatment indication, the Food and Drug Administration has not cleared these devices to be labeled for pedicle screw fixation and, therefore, has restricted industry supported educational activities pertaining to this type of treatment. In spite of the Food and Drug Administration's regulatory position, physicians have chosen to use pedicle screw fixation in treating patients who have a variety of spinal disorders. This use is now considered an accepted (state of the art) medical practice by many physicians for certain spinal conditions. This article explores this specific Food and Drug Administration regulatory issue, its impact on physicians and manufacturers (especially as it pertains to medical education), and recent actions taken to resolve it.

Bone Screws↗
PubMed1995

Intra-ocular lens.

Explore the source record for details and available documents.

Developing Countries↗
PubMed1997

The issue of a U.S. Food and Drug Administration moratorium on the use of the pulmonary artery catheter.

OBJECTIVE: To review the literature addressing the issue of a U.S. Food and Drug Administration (FDA) moratorium on use of the pulmonary artery catheter (PAC). DATA SOURCE: Pertinent English language articles dealing with medical devices including the PAC were retrieved from 1976 through 1996. STUDY SELECTION: Articles were chosen if issues related to medical devices were studied or reviewed. DATA EXTRACTION: From the articles selected, information about the 1976 Medical Device Amendment and the PAC was obtained. DATA SYNTHESIS: In 1976, the Medical Device Amendment gave the FDA power over medical devices. The pulmonary artery catheter is considered a class II device and was on the market before passage of the 1976 Act. Class II devices require general and specific controls to reasonably assure safety and effectiveness. A reasonable assurance of safety occurs when the probable benefits to health from the use of the device outweigh any probable risks. If a monitor measures an established and well-understood variable and the intended use claim is limited to the measurement of that variable, then the effectiveness consists of determining device safety and performance defined as the measurement of agreement with a recognized reference method. Deaths and serious injuries secondary to pulmonary artery catheterization are extremely rare despite more than 25 years of use. Pulmonary artery catheter manufacturer's indications for use are measurements such as hemodynamic pressures, thermodilution cardiac output, continuous cardiac output, mixed venous oxygen saturation, and blood sampling; intended uses have not included claims of clinical benefit. Evidence exists that pulmonary artery catheterization provides agreement with established measurements including pressure and cardiac output. Evidence also exists that pulmonary artery catheter derived data are unobtainable clinically, that the derived data helps in therapy changes and may lead to more appropriate therapy. The evidence demonstrates an absence of unreasonable risk of injury from pulmonary artery catheterization and provision of important clinical results. Therefore, pulmonary artery catheterization meets FDA requirements for safety and effectiveness. CONCLUSION: An FDA moratorium on the use of the PAC is not indicated.

Catheterization, Swan-Ganz↗
PubMed1997

19 mm sized bileaflet valve prostheses' flow field investigated by bidimensional laser Doppler anemometry (part I: velocity profiles).

The investigation of the flow field downstream of a cardiac valve prosthesis is a well established task. In particular turbulence generation is of interest if damage to blood constituents is to be assessed. Several prosthetic valve flow studies are available in literature but they generally concern large-sized prostheses. The FDA draft guidance requires the study of the maximum Reynolds number conditions for a cardiac valve model to assess the worst case in turbulence by choosing both the minimum valve diameter and a high cardiac output value as protocol set up. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, the Laboratory of Biomedical Engineering is currently conducting an in-depth study of turbulence generated downstream of bileaflet cardiac valves. Four models of 19 mm sized bileaflet valve prostheses, namely St Jude Medical HP Edwards Tekna, Sorin Bicarbon, and CarboMedics, were studied in aortic position. The prostheses were selected for the nominal annulus diameter reported by the manufacturers without any assessment of the valve sizing method. The hemodynamic function was investigated using a bidimensional LDA system. Results concern velocity profiles during the peak flow systolic phase, at high cardiac output regime, highlighting the different flow field features downstream of the four small-sized cardiac valves.

Aortic Valve↗
PubMed1997

19 mm sized bileaflet valve prostheses' flow field investigated by bidimensional laser Doppler anemometry (part II: maximum turbulent shear stresses)

The investigation of the flow field generated by cardiac valve prostheses is a necessary task to gain knowledge on the possible relationship between turbulence-derived stresses and the hemolytic and thrombogenic complications in patients after valve replacement. The study of turbulence flows downstream of cardiac prostheses, in literature, especially concerns large-sized prostheses with a variable flow regime from very low up to 6 L/min. The Food and Drug Administration draft guidance requires the study of the minimum prosthetic size at a high cardiac output to reach the maximum Reynolds number conditions. Within the framework of a national research project regarding the characterization of cardiovascular endoprostheses, an in-depth study of turbulence generated downstream of bileaflet cardiac valves is currently under way at the Laboratory of Biomedical Engineering of the Istituto Superiore di Sanita. Four models of 19 mm bileaflet valve prostheses were used: St Jude Medical HP, Edwards Tekna, Sorin Bicarbon, and CarboMedics. The prostheses were selected for the nominal Tissue Annulus Diameter as reported by manufacturers without any assessment of valve sizing method, and were mounted in aortic position. The aortic geometry was scaled for 19 mm prostheses using angiographic data. The turbulence-derived shear stresses were investigated very close to the valve (0.35 D0), using a bidimensional Laser Doppler anemometry system and applying the Principal Stress Analysis. Results concern typical turbulence quantities during a 50 ms window at peak flow in the systolic phase. Conclusions are drawn regarding the turbulence associated to valve design features, as well as the possible damage to blood constituents.

Aortic Valve↗