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- - 1998
The Food and Drug Administration (FDA) is amending the regulations governing humanitarian use devices. These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of ...
- - 1998
The Food and Drug Administration (FDA) is proposing to amend certain regulations governing humanitarian use devices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug, ...
Merrill R A - - 1998
Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products. The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority. This ...
- - 1998
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance on Medical Device Tracking." This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic Act (the act), as amended by the ...
Donawa M E - - 1998
United States (US) Food and Drug Administration (FDA) investigators have, for many years, consistently evaluated compliance with US process validation requirements. Until now there has been significant variability in the manner in which they have examined compliance with US requirements for the validation of software used in the production process ...
- - 1998
The Food and Drug Administration (FDA) is publishing a guidance entitled "S1B Testing for Carcinogenicity of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance outlines experimental approaches to evaluating the carcinogenic ...
Johnson S D SD Christine M. Kleinert Institute for Hand and Micro Surgery, Louisville, KY 40202, - - 1998
Behavior modification in rats often involves controlling the frequency of providing food rewards. This is accomplished with computer-controlled devices or equipment purchased specifically for this purpose. Investigators currently choose from a few commercially available models, but each has its disadvantages or limitations, including a high cost (about US$1000). Computer-controlled devices ...
Gaylor D W - - 1998
A brief overview is provided of some of the general safety and risk assessment procedures used by the different centers of the U.S. Food and Drug Administration (U.S. FDA) to evaluate low-level exposures. The U.S. FDA protects public health by regulating a wide variety of consumer products including foods, human ...
- - 1998
The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, ...
Golodner L F - - 1998
This paper provides a consumer's perspective on an important issue that has a profound impact on all of us: the US Food and Drug Administration (FDA) Modernization Act of 1997. In addition, it provides some background information on the National Consumers League, an organization that promotes consumer safety and protection ...
- - 1997
The Food and Drug Administration (FDA) is announcing that it is codifying the reclassification of tumor-associated antigen immunological test systems intended as an aid in monitoring patients for disease progression or response to therapy or for the detection of recurrent or residual disease from class III (premarket approval) to class ...
- - 1997
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding preemption of State and local requirements applicable to medical devices. This action is being taken to clarify and codify the agency's longstanding position that available legal remedies, including State common law tort claims, generally are not preempted ...
Gaylor D W - - 1997
The U.S. Food and Drug Administration (FDA) regulates a wide variety of consumer products. Safety issues involve chemical and microbial contaminants in food, biologies, and medical devices; side effects from prescription and nonprescription drugs; residues of animal drugs in food; and radiation from electronic devices. Because of this wide diversity, ...
Cismoski J - - 1997
The objective of this project was to profile the statewide enforcement of laws prohibiting sales of tobacco to minors and purchasing/possession of tobacco by minors in 1996. A sample of Wisconsin cities or villages (n = 86) were surveyed on adoption of pertinent state statutes as local ordinances and the ...
Kramer G H - - 1997
Monte Carlo simulations have been performed to evaluate the design of collimated detectors used to measure 125I or 131I in the thyroid gland. Two detector sizes were simulated for each radioisotope: (i) for 125I monitoring 2.54 cm diameter and 7.62 cm diameter and 0.2 cm thickness and (ii) for 131I ...
Taimela E - - 1997
We have established reference intervals for healthy adults of serum thyrotropin, free thyroxine and free triiodothyronine using the AutoDELFIA (Wallac, Finland) automatic measuring device. The determination of reference intervals in a proper manner is costly, and many laboratories adopt reference ranges from the literature rather than determining them alone. This ...
Stepanek J - - 1997
Avalanches are one of the major threats to life in high-mountain terrain and account every year for approximately 150 accidents causing injury or death in the United States alone. Every year avalanches cause significant property damages and a death toll of approximately 15 people in the United States. The specific ...
Savory C J - - 1997
1. This study investigated effects of plastic anti-pecking devices on food intake and behaviour to assess their applicability in commercial layer flocks. 2. In experiment 1, 72 individually caged ISA Brown pullets were fitted at 16 weeks of age (point of lay) with either 'ring' or 'bumper' beak devices or ...
Smith T M - - 1997
This paper provides an overview of the responsibilities and jurisdictional boundaries of Health Canada (HC) and Agriculture and Agri-Food Canada (AAFC) with regard to food regulation in Canada. It examines their interagency coordination within the federal structure and with other levels of government, industry, and the consumer. The international developments ...
Donawa M E - - 1996
This column in last month's edition discussed answers to some of the questions raised at a recent Food and Drug Administration (FDA) conference held in Paris. This article continues that discussion and includes questions and answers concerning harmonization and good manufacturing practice (GMP) requirements. As in the preceding column, the ...
Smith K M - - 1996
We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches ...
de la Macorra J C - - 1996
The configuration factor of adhesive cavities is defined as the ratio of the restoration's bonded to unbonded (free) surfaces. Such a configuration factor was described, on ideal cavities, as having a potential value in predicting the behaviour of the restorations, because it is related to the restoration's capacity for relieving ...
Rouhiainen P - - 1996
We evaluated the ability of Lensmeter 701 (LOM) to detect changes in the transparency of the lens graded with the Lens Opacities Classification System II (LOCS II). In this prospective study 410 middle-aged Eastern Finnish men participating in the Kuopio Atherosclerosis Prevention Study were examined three times at eighteen month ...
Nixon R - - 1996
Current "regulatory reform" in the U.S. Congress is seeking to eliminate the Food and Drug Administration. The author discusses the forces behind this reform and traces the impact of campaign contributions from various industries opposed to FDA regulations, stock held by members of Congress in companies regulated by the FDA, ...
Khambay B S - - 1995
Four commercially available electric toothbrushes (Sonicare, Braun Electric Toothbrush, Interplak, and Blend-a-Dent) were assessed both for their operating characteristics and their ability to remove a "food debris" medium. The Sonicare and Blend-a-Dent have a lateral vibratory action, while the Interplak and Braun produce a rotary movement of the brush head. ...
Kenawi M M - - 1995
A small cosmetic incision followed by 'squeeze delivery' was attempted for 190 lipomas in 116 patients. This technique was successful without resort to widening of the incision or using scissor dissection in 87 lipomas (46 per cent). Success was not related to size but to the site of the lipoma. ...
Pennington J A - - 1995
An International Interface Standard for Food Databases is under development to help overcome the technical and semantic barriers to the use of food-related databases. The Interface Standard is a system for efficient storage of all relevant descriptive information about foods. The schema for the Standard consists of ten components--food/food product ...
Holmes S N - - 1995
In the USA, any institution involved in using non-human primates for research has had, for regulatory reasons, to address the psychological needs of these animals. Enriching the environment through the use of foraging devices has been one method and a study was designed to evaluate the short-term effect of a ...
Matthews E J - - 1995
In response to the objectives of this ATSDR workshop, 2 new procedures are described for assessing the safe use of indirect food additives. First, this workshop provided a timely forum in which to describe a newly proposed Threshold of Regulation (T/R) Policy under which the Food and Drug Administration (FDA) ...
Kirby R L - - 1995
Evidence has been accumulating that injuries related to wheelchair use are common and sometimes serious. The object of this study was to evaluate the databases of the Food and Drug Administration (FDA) for insights to the nature and causes of such problems. We analyzed 651 records that were received by ...
Townsend J B - - 1995
Although there have been numerous presentations on how to conduct and survive a government inspection, it appears that these sessions do not always adequately include suggestions from those who have been the subjects of regulatory inspections. This paper will include comments from the experience of one of the regulated. Remarks ...
Richenbacher W E - - 1995
The successful use of mechanical ventricular assistance is, in large part, dependent upon easy insertion of well designed inflow and outflow cannulas. This manuscript describes a family of cannulas specifically designed for use in a nonpulsatile ventricular assist device (VAD) circuit. Although a variety of commercially available cannulas can be ...
Hallagan J B - - 1995
The generally recognized as safe (GRAS) assessment program of the Flavor and Extract Manufacturers Association (FEMA) of the United States was initiated in 1959 to provide for the assessment of flavor ingredients as GRAS under the Food Additives Amendment to the U.S. Federal Food, Drug, and Cosmetic Act. FEMA sponsored ...
Turro-Vincent I I Station de Recherches Avicoles, Institut National de la Recherche Agronomique, 37380 Nouzilly, - - 1995
Interactions between underlying fearfulness and social factors during the development of learnt food aversions was studied in two lines of Japanese quail selected for a long (LTI) or short (STI) duration of the tonic immobility response. Chicks of the LTI line have high inherent levels of fearfulness and chicks of ...
Kartush J M - - 1995
Conventional hearing aids have a number of limitations inherent to amplifying sound in the narrow confines of the external auditory canal. Disadvantages include acoustic feedback, poor fidelity, and the stigmata of aging. Since 1986, Michigan Ear Institute and Smith and Nephew Richards Company have been investigating the feasibility of a ...
Margolis M T - - 1995
The 3M Precise Microvascular Anastomotic System (MAS), a microvascular stapling device, was compared with microsurgery for the reanastomosis of rabbit fallopian tubes. Differences in operative time, tubal patency, adhesion formation, and fertility rate were studied in 18 rabbits. Only 17% of tubes repaired by MAS were subsequently patent by chromopertubation, ...
- - 1994
The Food and Drug Administration (FDA) is issuing this final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) that require all persons who submit a premarket notification (510(k)) to provide to FDA, as part of the submission, an adequate summary (510(k) summary) of ...
Waterfall A H - - 1994
Antibody microprobes are devices which have been used to determine the release sites of several neuropeptides. The production of microprobes using the previous methodology is a time-consuming procedure requiring a high level of skill. The aim of the study was to investigate alternative methods for the production of microprobes which ...
- - 1994
The Food and Drug Administration (FDA) is publishing a letter sent to known manufacturers of blood establishment computer software products. In the letter, FDA advised these manufacturers that it considers these computer software products to be devices under the Federal Food, Drug, and Cosmetic Act (the act) because these products ...
Watson J T - - 1994
The data submitted for Food and Drug Administration (FDA) review of medical devices are often not approved because of poor study design. This article proposes a new approach for developing FDA study design guidance through panels of colleagues from the academic, federal, and private sectors. This piece focuses discussion and ...
Poustis J - - 1994
The authors have undertaken a series of mechanical tests in order to assess the performance of regenerated cellulose under either static or dynamic conditions, and to evaluate its long-term behaviour under mechanical stress. In this respect, bending stiffness, resistance to compression, creep under compressive stress, in vitro and in vivo ...
Casey S M - - 1993
A study was conducted to evaluate mobile roadside speedometers as a means of controlling urban traffic speeds under varied schedules of deployment and speed limit law enforcement. Speeds of cars passing the roadside speedometer were measured using nondetectable radar. The data indicate that, generally, the speedometer's presence reduced average traffic ...
McClain L - - 1993
This study was designed to determine the compliance of restaurants to the wheelchair accessibility standards set forth in the Uniform Federal Accessibility Standards. The standards that were operationalized in this study are also found in Title III of the Americans With Disabilities Act of 1990. The data were collected at ...
Wessely S - - 1993
Associations between delusions and abnormal behaviour were retrospectively assessed in a sample of 83 consecutively admitted deluded subjects. All were interviewed about events in the previous month using a new measure of delusional phenomenology and action. For 59 subjects this information was supplemented by informant interviews. Clinical consensus was reached ...
Ricer R E - - 1993
By law, cigarette advertisements in magazines must contain one of four surgeon general's warnings and these warnings must be rotated quarterly. This study surveyed the top 13 magazines by paid subscription in the United States that accept cigarette advertising to determine if cigarette companies are compliant with this law. All ...
- - 1993
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to redelegate the authority of the Assistant Director for Health to make determinations to close advisory committee meetings to the public to the Commissioner of Food and Drugs (the Commissioner) and other agency heads. FDA is ...
- - 1993
The Food and Drug Administration (FDA) is announcing the reclassification and codification of the hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. FDA issued an order in the form of a letter to two manufacturers reclassifying the device from class III into class II. Accordingly, FDA is amending the regulations as ...
Bobka M S - - 1993
The Code of Federal Regulations, Title 21 (21 CFR), contains the U.S. federal regulations for every product regulated by the Food and Drug Administration and Drug Enforcement Administration, including pharmaceuticals, veterinary products, medical devices, cosmetics, and foods. A new online database, 21CFR Online, now allows access to the full-text of ...
- - 1992
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals. Specifically, this rule eliminates recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug ...
Denstedt J D - - 1992
Modalities available for performing intracorporeal lithotripsy include ultrasonic, electrohydraulic and laser procedures. We present our experience with a new and unique technology for performing intracorporeal lithotripsy, namely the Swiss Lithoclast. This simple and inexpensive device uses compressed air to activate a solid probe in a manner similar to that of ...
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