The FDA performs scientific and clinical reviews of the contents of 510(k) submissions to determine whether the device is substantially equivalent to a predicate device already in commercial...
Search Results "Substantial Alteration"
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2.5.1 U.S. Food and Drug Administration
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Sweep Width
width for bike lanes as 1.2 m (4 ft).(2) Additionally it recommends (pp. 35-36) a minimum width of 3 m (10 ft) for a two-way shared use path (and a wider path is desirable where there is substantial...
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University of Alabama at Birmingham (UAB) ADA Professional Training Certificate Program
From the convenience of your location and on your schedule, you can enjoy these powerful courses which feature substantial group interaction, relevant case law and real-life applications...
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4.1 Introduction
The idea that a control or operable hardware located on a plane in front of the user can be accessible with a forward reach, regardless of the height, is not substantiated by this research...
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Lines of Sight for Wheelchair Spaces
Wheelchair spaces are required to be dispersed to provide users with choices of seating locations and viewing angles substantially equal to or better than the choices afforded all other...
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Rulemaking Process
And so very often they deliver us a product that has to be pretty substantially changed, at least in its format, in order to be an acceptable guideline or standard that would be enforceable...
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Subpart E—Enforcement (Preamble, Section-by-Section Analysis)
grounds for believing that he or she is ‘‘about to be’’ subjected to discrimination in violation of section 303 of the Act (subpart D of this part), which requires that new construction and alterations...
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g. Discussion of Significant Regulatory Alternatives That Minimize Impact on Small Entities
otherwise treated differently than other individuals because of the absence of auxiliary aids and services, unless the entity can demonstrate that taking such steps would fundamentally alter...
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ASME
ASME A17.1 is used by local jurisdictions throughout the United States for the design, construction, installation, operation, inspection, testing, maintenance, alteration, and repair of...
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30. - 34.
The Museum may, in its discretion, choose to submit plans to the Department for any other alterations or new construction....
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ACCESSIBILITY
New construction and alterations commencing on or after March 15, 2012, are subject to new design standards under the Title II regulations, and these standards include specific requirements...
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K) Temporary Events
Facilities and structures that are built or altered for temporary use must comply with the ADA Standards (except for construction trailers)....
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Work Areas [4.1.1(3)]
., designed so that certain elements can be added or altered for access after construction)....
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Using a Fitness Center Does Not Have to be an Exercise in Frustration: Tips for People with Mobility and Visual Disabilities
Permission is granted to copy and distribute this material provided that: Proper copyright notice and citation is attached to each copy; No alterations are made to the contents...
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BACKGROUND
Implementing regulations under Title II of the Americans with Disabilities Act (1) and other statutes require that new construction and alterations are accessible to, and useable by, people...
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Foreword, July 26, 1997
It has altered our public discourse about disability and about the role of people with disabilities in American society....
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Implementation and Enforcement
court to be unenforceable, the other terms of this Agreement shall nonetheless remain in full force and effect, provided, however that if the severance of any such provision materially alters...
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11B-203.9 Employee workstations
Under the ADA, employees with disabilities are entitled to reasonable accommodations in the workplace; accommodations can include alterations to spaces within the facility....
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11B-203.9 Employee workstations
Under the ADA, employees with disabilities are entitled to reasonable accommodations in the workplace; accommodations can include alterations to spaces within the facility....
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Public Postsecondary Schools
Postsecondary schools are not required to lower or substantially modify essential requirements....
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2.1 Health Care Experiences of Persons with Disabilities
Survey (NHIS) D about mammography screening and Pap testing among women with and without disabilities. 6 As shown in Table 2.1, women with self-reported disabilities of different types are substantially...
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Accessible Route
This commenter argued that if golf car passages were required to extend onto teeing grounds and greens in order to qualify for an exception, then some golf courses would have to substantially...
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TITLE III COVERAGE AND FINDINGS
The Cantrells both have a physical impairment which substantially limits the major life activities of hearing, speaking, receptive spoken communication, and expressive spoken communication...
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Section 504 of the Rehabilitation Act (Section 504)
Under Section 504, as under Title II, a disability is (1) a physical or mental impairment that substantially limits a major life activity; (2) a record of such an impairment; or (3) being...