This document addresses adaptive designs for medical device clinical studies and is applicable to premarket medical device submissions including Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions (Evaluation of Automatic Class III Designation), Humanitarian Device Exemption (HDE) applications and Investigational Device Exemption (IDE) submissions. This guidance can be applied throughout the clinical development program of a medical device, from feasibility studies to pivotal clinical studies. This guidance does not apply to clinical studies of combination products or co-development of a pharmaceutical product with an unapproved/uncleared diagnostic test. However, the underlying principles may be applicable to such studies.
Evidence-based public health decisions are based on evaluations of intervention studies with randomized and nonrandomized designs. Transparent reporting is crucial for assessing the validity and efficacy of these intervention studies, and, it facilitates synthesis of the findings for evidence-based recommendations. Therefore, the mission of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) group is to improve the reporting standards of nonrandomized evaluations of behavioral and public health interventions.
The TREND statement was first published in a special issue of the American Journal of Public Health in March 2004. The issue was devoted to evaluation research. This special issue contains a number of papers related to the use of nonrandomized or quasi-experimental designs in the evaluation of interventions.
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Industrial designs are applied to a wide variety of products of industry and handicraft items: from packages and containers to furnishing and household goods, from lighting equipment to jewelry, and from electronic devices to textiles. Industrial designs may also be relevant to graphic symbols, graphical user interfaces (GUI), and logos.
The Standing Committee on the Law of Trademarks, Industrial Designs and Geographical Indications (SCT) is the forum where WIPO's member states and observers meet to address issues relating to the development of the international legal framework for industrial designs. SCT members are currently seeking agreement on a number of key issues relating to international designs.
The Hague System for the international registration of industrial designs offers the owner of an industrial design a means of obtaining protection in several countries by filing one application in one language, with one set of fees in one currency.
The Global Design database enables simultaneous searches via a single, intuitive interface across all international industrial designs registered under the Hague System as well as in participating national collections.
Our Design Challenge is where customers and artists vote on the best work to bring to you. The benefits are many: You get exclusive fresh designs, and artists thrive in our uniquely supportive creative community.
The journal provides a venue for designers to share their knowledge-in-practice through rich representations of their designs and detailed discussion of decision-making. The aim of the journal is to support the production of high-quality precedent materials and to promote and demonstrate the value of doing so. Audiences for the journal include designers, teachers and students of design and scholars studying the practice of design.
Providing inspiration and solutions for machine embroidery enthusiasts Eileen Roche shares her wealth of machine embroidery and sewing experience to create products for embroiderers of any skill level. Her talent, creativity and enthusiasm distinguish her from others in the industry and are the driving force behind the success of Designs in Machine Embroidery Inspiration events and the products available online and in dealers across the United States and beyond. Designs in Machine Embroidery is the source for machine embroidery products including how-to and educational books, machine embroidery hoops, machine embroidery tools and organizers, machine embroidery designs, instructional videos, embroidery thread, stabilizers and more. Designs in Machine Embroidery is focused on inspiring and educating readers on all aspects of machine embroidery. Thank you stopping by.
The American Women Quarters Program is a four-year program that celebrates the accomplishments and contributions made by women of the United States. Beginning in 2022, and continuing through 2025, the U.S. Mint will issue up to five new reverse designs each year. The obverse of each coin will maintain a likeness of George Washington, but is different from the design used during the previous quarter program.
The advanced reactors selected for risk-reduction awards are an excellent representation of the diverse designs currently under development in the United States. They range from advanced light-water-cooled small modular reactors to new designs that use molten salts and high-temperature gases to flexibly operate at even higher temperatures and lower pressures.
Two ARDP demonstration projects are currently moving forward as TerraPower and X-energy aggressively work with their teams to plan for and ultimately deliver operational reactors within the next seven years. And, although these designs may be further along in the technology development process at this time, we recognize that other domestic vendors need additional financial, technical, and regulatory support to mature their designs.
In addition to these five designs, we also awarded $20 million on less mature, but novel advanced reactor designs later this month. The funding will further support their concept development in order to demonstrate these promising reactors by the mid-2030s. 041b061a72