The FDA-CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access...
Search Results "Regulatory Impact Analysis"
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F. Consultation with Food and Drug Administration
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IV. Significant Changes to the NPRM
Individual provisions of the rule are discussed in detail under the Section-by-Section Analysis below....
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§ 37.75(c)
remanufacture a bus or other motor vehicle so as to be readily accessible to and usable by individuals with disabilities, including individuals who use wheelchairs, unless an engineering analysis...
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Sections 35.108(d)(1)(v) and 36.105(d)(1)(v)—Comparisons to Most People in the Population, and Impairment Need Not Prevent or Significantly or Severely Restrict a Major Life Activity
The preamble to the Department’s 1990 title II and title III regulations also referenced that the impact of an individual’s impairment should be based on a comparison to most people....
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Undue Hardship
unpredictable (for example, the specific day that an employee needs leave because of a seizure is unpredictable; intermittent leave to obtain chemotherapy is predictable); the impact...
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C. Technical standards for content validity studies
(2) Job analysis for content validity. ...
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2.3.2. Device Acquisition
These costs are also presented separately in the analysis. ...
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2.2.5 Grip Strength
WhMD users were required to perform three maximal efforts in each of the four types of grips with their dominant hand, with the mean value considered as the maximal force value for analysis...
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Biodex BioStep® 2 Semi-Recumbent Elliptical Machine
The BioStep 2 reduces joint impact because the user is not required to lift and strike their feet on the walking surface....
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American Stair Corp. Standard Railings
These designs will meet or exceed current code and regulatory requirements....
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Exclusion of Individuals with HIV or AIDS
A direct threat analysis must be individualized, finding a significant risk to the health or safety of others that cannot be eliminated or reduced to an acceptable level by reasonable modifications...
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§1630.2(j)(1)(iii)
Accordingly, the threshold issue of whether an impairment “substantially limits” a major life activity should not demand extensive analysis....
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Good Practices of Accessible Urban Development: Making Urban Environments Inclusive and Fully Accessible to ALL
Accessible Urban Development: Making Urban Environments Inclusive and Fully Accessible to ALL (86-page PDF) Introduction1 "Persons with disabilities have a significant positive impact...
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Pit Toilet
A pit toilet may be permanently installed or may be moved from one location to another as the pit is filled or the area becomes severely impacted from use. ...
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Pit Toilet
A pit toilet may be permanently installed or may be moved from one location to another as the pit is filled or the area becomes severely impacted from use....
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Van Spaces
Since spaces can share an aisle, two van spaces can be provided instead of one without any space impact....
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Meeting Room Layouts and Considerations
The layout of your meeting, event, or conference will dramatically impact the way attendees engage with your program and with one another....
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Pit Toilet
A pit toilet may be permanently installed or may be moved from one location to another as the pit is filled or the area becomes severely impacted from use. ...
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II-9.2000 Complaints
to: Office for Civil Rights, Department of Education, 330 C Street, S.W., Suite 5000, Washington, D.C. 20202. 3) Department of Health and Human Services: All programs, services, and regulatory...
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8.10 Laws and Regulations Concerning Drugs and Alcohol
for airline employees, interstate motor carrier drivers and railroad engineers; and regulations for safety sensitive positions established by the Department of Defense and the Nuclear Regulatory...
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Paperwork Reduction Act
They would also have to make a comparison between using car-borne lifts and other means of meeting the regulatory performance standard (see section 37.42(d)(1))....
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NOTES
See Analysis of Seat Heights for Wheeled Mobility Devices at: http://udeworld.com/analysis-of-seat-height-for-wheeled-mobility-devices. ...
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Notes
Notes GG Analysis of Seat Heights for Wheeled Mobility Devices. The study is available at http://udeworld.com/analysis-of-seat-height-for-wheeled-mobility-devices....
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Incorporation of Guidelines for Play Areas and Recreation Facilities
The Board developed the guidelines through regulatory negotiation, a supplement to the traditional rulemaking process that allows face-to-face negotiations among representatives of affected...
