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NSENational Stock Exchange (of India Ltd)
NSENigerian Stock Exchange
NSENairobi Stock Exchange
NSENational Stock Exchange (Lithuania)
NSEneuron-specific enolase
NSENanoscale Science and Engineering
NSENational Society for Epilepsy
NSENeedle and Syringe Exchange (HIV protection)
NSENaval Station Everett (Everett, WA)
NSENucleus Software Exports Ltd. (India)
NSENu Skin Enterprises (Provo, UT)
NSENetwork Services Engine
NSENetwork Software Environment
NSENegative Stuff Event
NSENamed Signaling Event
NSENetwork Support Encyclopedia
NSENetwork Storage Executive
NSENetwork Services Engine (Cisco)
NSENational Support Element
NSENagoya Stock Exchange
NSENetwork Search Engine
NSENigerian Society of Engineers (Abuja, Nigeria)
NSENonprofit Social Enterprise (model)
NSENetwork Southeast (UK)
NSENeutron Spin Echo
NSENot Soon Enough
NSENuclear Safety Evaluation (various locations)
NSENippon Steel Engineering (Japan)
NSENorth South Expressway
NSENot Substantially Equivalent (FDA)
NSENeutral Stream Etch
NSENamespace Extension (Microsoft Windows Shell)
NSENaval Support Element
NSENetwork Storage Executive (Veritas)
NSENetwork Service Entity (GPRS)
NSENetwork Services Engineer
NSENetwork Simulations Engineer
NSENaval Shore Establishment
NSENetwork State Evolution
NSENon-Deployed Shorebased Equipment (Navy)
NSENo Stuff Einstein (polite form)
NSENetwork System Engineering Group (MCI)
NSENetwork Switching Element (Bellcore)
NSENoise Spectral Estimator
NSENCOIC Standardization and Evaluation
NSENetworking Systems Engineer
NSENuance Security Engine (software)
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References in periodicals archive ?
"In addition to the 21 substantial equivalence orders received by Xcaliber, approximately 115 products manufactured by the company have been removed from scientific review as part of that regulatory action."<br />Under federal law, products that are provisionally marketed are subject to a finding by the FDA that they are either substantially equivalent to a product marketed in February 2007 or not substantially equivalent to that predicate tobacco product.<br />
Advise on development of rules to provide a clear pathway to initial licensure for graduates of out-of-state programs the Board determines are not substantially equivalent to Board standards for Texas programs;
Information obtained from an early feasibility study may guide device modifications." Because the early device is usually not substantially equivalent to the final commercial device, this study is not part of the final FDA submission.
Dexcom said that the FDA reviewed the mobile app software used with the Dexcom Share receiver through its de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device.
Jash International's Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone were found, By FDA, as not substantially equivalent to tobacco products that were previously sold as of Feb.
"In 93 percent of the submissions analyzed, the sponsor had either failed to address questions raised in the initial AI letter and/or provided information in response to the deficiencies that did not support a determination that the device was substantially equivalent and, therefore, FDA sent a second M letter to give the sponsor a second opportunity to address these problems rather than determine that the device is not substantially equivalent," the FDA report stated.
The discrepancies between the actual state law treatment of these entities led both the Court of Federal Claims and the Tax Court to conclude that LLCs and limited partnerships were not substantially equivalent entities for this purpose and that there was no justification for presuming LLC interests are passive absent a clear provision in the law requiring such treatment.
"With these orders, Xcaliber is poised to better serve its wholesale and retail partners in the 40-plus states in which we operate."<br />Under federal law, products that are provisionally marketed are subject to a finding by the FDA that they are either substantially equivalent to a product marketed in February 2007 or not substantially equivalent to that predicate tobacco product.
The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified.
Historically, this required that medical device firms first submit a 510(k) premarket notification, arguing that the device is substantially equivalent to a predicate device, and receive a negative (a not substantially equivalent or NSE finding) finding from the agency.
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