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SESpecial Edition
SESoutheast
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SESelf Employed
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SESoftware Engineering
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SESpecial Education
SESex Education
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SESweden (Internet top-level domain)
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SESound Effect
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SESociety and Environment (school subject)
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SEStandard Error (statistics)
SEStructural Engineer
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SEStraight Edge (philately)
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SELondon Southeast (UK postcode)
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SESocial Engineering (computers)
SESpecial Envoy
SEState Engineering (Pakistan government)
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SEsquare error
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SESystem Expansion (Apple Macintosh)
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SESergipe (Brazil)
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SESony Electronics
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SEStatus Epilepticus
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SESpin-Echo
SESplit End (similar to wide receiver; football)
SESu Excelencia (title of address)
SEStimulated Emission
SEStandard Examiner (newspaper)
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SESystems Europe (Belgium)
SESystem Environment
SESpongiform Encephalopathy
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SEScreaming Eagles (soccer club; Washington, DC)
SESpectral Efficiency
SESelf Evident
SEShift Engineer
SESarjana Ekonomi (Indonesian: Bachelor of Economics)
SESpace Elevator
SEStudent Expectations
SESomatic Experiencing (mental health)
SEStandard English
SESpectroscopic Ellipsometry
SESocietas Europaea (European public limited-liability company)
SESiege Engine (gaming)
SEStorage Element
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SESenior Engineer
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SESpectrum Engineering
SESand Equivalent (civil engineering)
SESupplies & Equipment
SEStable Element
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SEStudent Experiment (NASA)
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SEStatus Entry (Hekimian)
SESerrated Edge
SEStroboscopic Effect
SEStarr-Edwards (heart valves)
SEService Économique (French: Economic Service; French Embassy)
SESuperelevation
SESafety Evaluation
SEStandards Executive
SESafety Engineer
SESharky Extreme
SESpreading Efficiency (amount of information bits conveyed by each chip)
SEService Evaluation (AT&T)
SESurvival Equipment
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SEStatic Encephalopathy (alcohol exposed)
SESystematic Error
SESpezial Electronic (German electronic company)
SESoftware Evolvability (IEEE International Workshop)
SESupport Element
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SESecondary Electron
SESaban Entertainment
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SESuperintending Engineer
SESlovenské Elektrárne (Slovak: Slovak Power Plants; est. 2002; Slovakia)
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SESecurity Escort
SEStrategic Ecosystem
SESingles Encounter
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SESynthetic Environment
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SESurrogate Endpoint
SESwitching Element
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SEScientific Editing
SESelf-Emulsifying
SEStratic Energy Corporation (Calgary, Canada; stock symbol)
SESeptember Eleventh
SESitus Est (Latin: It Is Located; epigraphy)
SESalem Elementary
SESyntax Element (video coding)
SESupporting Establishment
SESwine Erysipelas
SESerial Enable
SESucrose Equivalence (food measurement)
SESurveillant d'Externat (French: Supervisor of Clerkship)
SESquare Enix, Ltd
SEsurface de l'exploitation
SEScrewed Ends
SESupplier Exchange
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SESalmonella Enteritides
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SESaami, Northern (Norwegian ISO Language Code)
SESingle-Ended, Cyclindrical Boiler (US Navy)
SESheets & Equipment (NYC Transit Authority)
SESocietas Eruditorum (Latin: People at the Place of Learning)
SESystems Engineering and Integration Office (NIMA)
SESignal Excess
SESynchronous Editing
SESmall Eagles (Egypt)
SESynchronization Element
SESupportable Evaluation
SEStatiese Enkefalopatie
References in periodicals archive ?
* Substantial equivalence comparison between devices in different classifications (e.g., intervertebral body fusion devices and vertebral body devices);
If one applicant or company has successfully received Novel Food authorization based on extensive and costly research, then competitors can apply on the European national level for substantial equivalence of their comparable products.
The organization said then that "reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective."
A device applying for 510(k) clearance must show "substantial equivalence" to a device already given the OK by the agency (compared to higher classes of devices or novel technology that must undergo the more rigorous pre-market approval process, which often required years of research and clinical data).
As part of the provisional period, the company had to submit a substantial equivalence (SE) application to the FDA by March 22, 2011, in order for the products to remain on the market.
* The 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination.
In addition to the guidance being issued today, the agency had previously published additional resources to aid industry application submissions, including the proposed rule on Substantial Equivalence Reports and Tobacco Product Master File Guidance, and has conducted a public meeting and educational webinars describing, among other things, the statutory requirements for premarket applications.
The criteria document makes it clear that the Food and Drug Administration status of a device does not substantiate device accuracy, stating, "substantial equivalence, as defined by the FDA and used for 510(k) device clearance, is not sufficient to meet the criteria for clinical accuracy."
Food and Drug Administration, Center for Tobacco Products finding certain tobacco products that it manufactures to be "substantially equivalent" within the meaning of the 2009 Family Smoking Prevention and Tobacco Control Act.<br />"In April 2018, the FDA announced that approximately 1,500 products were to be removed from scientific review, pending the development and publication of regulations further outlining the substantial equivalence process," stated Eric Estes, general counsel for the Pryor-based cigarette manufacturer.
M2 EQUITYBITES-May 16, 2018-Xcaliber International issued substantial equivalence order for domestic cigarette market from the US FDA
In those instances, the device received 510(k) clearance but the consent did not apply to the particular products for which I was seeking substantial equivalence justification.
The FDA published a draft guidance "Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria" that provides the agency's proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification--called 510(k)--submissions through the Abbreviated 510(k) program.