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Topic: HDE

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	Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry
		An HDE applicant or holder who believes that he/she cannot comply with or should not be held to GMP standards may request an exemption from the Quality Systems Regulation.
		HDE amendments and supplements are subject to the same regulations as those for PMAs.
		In accordance with the HDE regulation, however, an applicant seeking a new indication for use of an approved HUD must obtain a HUD designation for the new indication for use and submit a new original HDE.
	www.fda.gov /cdrh/ode/guidance/1381.html (2699 words)

	Henry Draper Catalogue - Wikipedia, the free encyclopedia
		Stars in the range 225301-359083 are from the 1949 extension of the catalogue.
		The notation HDE is used only for stars in this extension (Henry Draper catalogue Extension), but even these are usually denoted HD as the numbering ensures that there can be no ambiguity.
		This page was last modified 16:56, 28 November 2005.
	en.wikipedia.org /wiki/HDE (237 words)

	College of Human Development and Education / College News and Info (Site not responding. Last check: 2007-10-13)
		HDE 189 and HDE 120 are required on all current curricula in the College of Human Development and Education.
		HDE 189 is required of all entering freshmen and new students who
		HDE 120 is required of all entering freshmen and new students who transfer fewer than 24 credits.
	www.ndsu.nodak.edu /hde/handbook/hde-hndbk-hde-189-infor.html (199 words)

	FDA > CDRH > CFR Title 21 Database Search
		An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of FDA, for the same reasons and in the same manner as prescribed for PMA's in 814.37, except that the timeframes set forth in 814.37(c)(1) and (d) do not apply.
		An HDE or HDE supplement may be temporarily suspended for the same reasons and in the same manner as prescribed for PMA's in 814.47.
		The HDE holder is responsible for ensuring that a HUD approved under this subpart is administered only in facilities having an Institutional Review Board (IRB) constituted and acting pursuant to part 56 of this chapter, including continuing review of use of the device.
	www.accessdata.fda.gov /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=814&showFR=1&subpartNode=21:8.0.1.1.11.7 (3453 words)

	HDE (Site not responding. Last check: 2007-10-13)
		HDE will be in the HUB, Room 108, on Friday, Feb. 19, from 9am to 2pm.
		Headquartered in Kent, Washington, HDE is an internationally recognized authority in the printer industry that provides a full range of software technology, hardware and market services specifically targeting OEMs.
		HDE services available cover the complete spectrum from consulting, technology licensing, host and embedded software development, to fully integrated designs.
	www.cs.washington.edu /affiliates/meetings/recruit99/hde.html (204 words)

	HDE 319718 (Pis 24-1) and the Pismis 24 Cluster (Site not responding. Last check: 2007-10-13)
		HDE 319718 (Pis 24-1) and the Pismis 24 Cluster
		HDe 319718, also known as Pis 24-1, sits in the cluster Pismis 24, at RA 17
		But the earlier O4(f) classification may reflect a real variation in brightness, especially if HDE 319718 is in fact an LBV star.
	www.tim-thompson.com /hde319718.html (355 words)

	Starboard forum - HDE vs Dram (Site not responding. Last check: 2007-10-13)
		What is an HDE board with a full EVA deck.
		EVA is a soft and a very skin-friendly surface material, but it adds a little bit of weight.
		HDE means "Heavy Duty Edition", so the boards should be a little bit more resistant to wear & tear.
	www.star-board.com /Forum/askteam/read.asp?ID=4211&t=2004126134132 (69 words)

	WELCOME to HDE, Inc (Site not responding. Last check: 2007-10-13)
		HDE is ready to meet all of your Tubing, Casing and Drilling Equipment needs.
		Established in 1990, by owner and president, Rickey A. Holloway, HDE has a reputation for supplying quality equipment and service to the oilfield industry, locally and internationally.
		HDE also provides a complete repair facility available to service your Tubing, Casing and Drilling Equipment.
	www.hollowaydrilling.com (154 words)

	Hog barn dust extract stimulates IL-8 and IL-6 release in human bronchial epithelial cells via PKC activation -- ...
		HDE at 1 h = 1,171 ± 298 pg/ml, at 3 h = 7,993 ± 610 pg/ml, at
		HDE at 1 h = 905 ± 277 pg/ml, at 3 h = 10,234 ± 2,763 pg/ml, at
		Effect of HDE after detoxification with polymyxin B. was eluted from a polymyxin B column to bind endotoxin (Detox) before use in some experiments.
	jap.physiology.org /cgi/content/full/93/1/289 (6031 words)

	"timeout waiting for DMA" causing boot delay - Ubuntu Forums
		hde is my linux boot drive (on a dual-boot system).
		It (hde) is an IBM IC35L040AVVA07-0 that is about two years old.
		The one thing this is unusual about my setup is that this drive (hde) is plugged into one of the two IDE channels on an Adaptec ATA RAID 1200A PCI card.
	www.ubuntuforums.org /showthread.php?t=9914 (995 words)

	Starboard forum - DRAM or HDE (Site not responding. Last check: 2007-10-13)
		Is it worth going for HDE or does it really not provide much diffrence then the DRAM as far as protection goes?
		DRAM is the least expensive, WOOD is the highest performance, and HDE is really designed for rental and hire operations where damage is most likely to occur.
		One last question, do you think that the carve 145 either DRAM or HDE would be able to perform basic freestyle and wave riding in some 20+knots?
	www.star-board.com /Forum/askteam/read.asp?ID=4447&t=2005213215629 (608 words)

	Home (Site not responding. Last check: 2007-10-13)
		Over 9 years ago HDE saw the need for competitively priced, yet reliable robotics systems for use in bomb disposal, SWAT, HAZMAT, and nuclear, biological, and chemical response.
		All of the robots available, both then and now, were priced beyond the reach of many departments across the country and the world.
		HDE has always listened to our customers in order to refine and develop products that meet their needs.
	www.hdemfg.com (209 words)

	AAOS Online Bulletin (Site not responding. Last check: 2007-10-13)
		Under the HDE pathway, the FDA authorizes marketing of the HUD specifically for the indication(s) noted on the HDE application.
		However, provisions in the HDE regulatory pathway include both a requirement for IRB approval and additional strong recommendations for physicians who intend to employ such devices for any off-label uses.
		The physician and the HDE holder (manufacturer) should follow FDA emergency use procedures governing the use of unapproved devices.
	www.aaos.org /wordhtml/bulletin/aug05/fline5.htm (1225 words)

	FDA > CDRH > 510(k) Premarket Notification Database Search
		The regulation provides for the submission of an humanitarian device exemption (HDE) application, which is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.
		An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.
		Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.
	www.accessdata.fda.gov /scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm (1857 words)

	HDE (Site not responding. Last check: 2007-10-13)
		HDE will be in the HUB, Room 108, on Friday, Feb. 27, from 9am to 2pm.
		HIRING NEEDS: HDE is a high technology company that develops embedded software and Windows device drivers for peripherals and PCs.
		HDE's highly skilled professionals enjoy a casual, friendly and challenging work environment that avoids bureaucracy and promotes close interaction with peers.
	www.cs.washington.edu /affiliates/meetings/recruit/hde.html (352 words)

	Hog barn dust extract stimulates IL-8 and IL-6 release in human bronchial epithelial cells via PKC activation -- ...
		A 5% dilution of HDE typically stimulates an approximately
		Detoxification of HDE with polymyxin B to remove endotoxin
		endotoxin is not solely responsible for HDE augmentation of PKC.
	jap.physiology.org /cgi/content/abstract/93/1/289 (316 words)

	HDE
		Its companion star, HDE 226868 is a B0 supergiant with a surface temperature of
		Physical map location of a set of Escherichia coli genes (hde...
		During the BeppoSAX observations HDE 245770, the optical counterpart to
	www.mongabay.com /reference/environment/HDE.html (226 words)

	Business Wire: DP-Tek Development Co. announces strategic alli... @ HighBeam Research (Site not responding. Last check: 2007-10-13)
		HDE has maintained a close relationship with Microsoft since 1989 and is now a Microsoft Authorized Support Provider for Windows Printing Software.
		Headquartered in Kent, Wash., HDE is an internationally recognized authority in the printer industry that provides technology and market services specifically targeting printer OEMs.
		HDE Inc. corporate address is 16613 SE 254 Place, Kent, WA, 98042.
	www.highbeam.com /library/doc0.asp?DOCID=1G1:17494347&refid=holomed_1 (703 words)

	Humanitarian Device Exemption (HDE)
		A Humanitarian Use Device (HUD) is a device that has been given special approval by the FDA under the Humanitarian Device Exemption (HDE) regulations.
		However, the FDA recognizes that sometimes a condition is so unusual that it would be difficult for a company to scientifically demonstrate effectiveness of their device in the large number of patients that usually must be tested.
		A Humanitarian Use Device may only be used in facilities that have an Institutional Review Board (IRB)* to supervise clinical testing of devices and after the IRB has approved the use of the device to treat or diagnose the specific disease.
	www.clevelandclinic.org /health/health-info/docs/3400/3453.asp?index=11629 (440 words)

	Heroldo de Esperanto (Site not responding. Last check: 2007-10-13)
		Post la milita paŭzo HdE reaperadis, kiel duonmonata sed fakte jam trisemajna, daŭre en Nederlando, daŭre sub la gvido de Teo Jung, daŭre relative antagonisma al UEA, interalie subtenante la atistojn en la povokonflikto, kamuflita per lingva demando, konata kiel la ATA/ITA-batalo.
		HdE fariĝis la opozicia gazeto, konstante batalanta kontraŭ Ivo Lapenna, ĝis lia retiriĝo en 1974.
		Sub la nova posedanto HdE fariĝis pli sendependa de la tradicia E-movado, prezentante la vidpunkton de ĉiuj partioj.
	www.esperantio.net /heroldo.php (321 words)

	Products (Site not responding. Last check: 2007-10-13)
		HDE Manufacturing, Inc. offers a variety of robotics related products to serve the needs of the professional bomb technician, SWAT officer, and hazardous material technician.
		The MURV-100-S is our standard robot system modified to deliver sensing instruments into a potentially dangerous area and remotely transmit data to an operator in a safe area.
		HDE offers a wide variety of affordable accessories that greatly increase the capabilities of our robot systems.
	www.hdemfg.com /products.htm (164 words)

	FDA Advisory Panel Voted ABIOMED's AbioCor(R) Submission Did Not Yet Meet HDE Standards; Additional Data is Requested
		The panel then voted seven to six, with one abstention, that the submission did not meet HDE requirements.
		Approval under an HDE would make the AbioCor commercially available to treat a defined subset of not more than 4,000 irreversible end-stage heart failure patients.
		The AbioCor is designed to sustain the body's circulatory system and to extend the lives of patients who would otherwise die of heart failure.
	www.prnewswire.com /cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-23-2005/0003934904&EDATE= (705 words)

	Sennheiser Worldwide: HDE 1030 - 03880
		Charging unit for charging 10 BA 90 accupacks in the HDE 1030 receivers.
		Plug-in mains unit for supplying the L 29-50-2 charging case, two to five cascaded L 151-10 charging units or up to five L 1030-10 charging units.
		System case with chargers for 20 HDE 1030 receivers and a compartment for the L 1032 charger.
	www.sennheiser.com /sennheiser/icm_eng.nsf/root/03880 (289 words)

	The survival characteristics of dense sickle cells -- Franco et al. 96 (10): 3610 -- Blood (Site not responding. Last check: 2007-10-13)
		HbF in the HDE RBCs, the circulation half-time was 40, 80, and
		F cells have longer in vivo survival than HDE non-F cells.
		HDE sickle cells, especially those that do not contain HbF, have
	www.bloodjournal.org /cgi/content/abstract/96/10/3610 (396 words)

	High-dose Epinephrine Is Not Superior to Standard-dose Epinephrine in Pediatric In-hospital Cardiopulmonary Arrest -- ...
		HDE during resuscitation from 24 arrests, at a dose of 0.12 ±
		HDE and SDE groups were not significantly different in terms of
		In this study, the use of HDE did not improve the rates of ROSC, short-term survival, or long-term survival after
	pediatrics.aappublications.org /cgi/content/abstract/99/3/403 (570 words)

	Standard, HDE or CCPM??? (Site not responding. Last check: 2007-10-13)
		Also in case of crash some have reported on CCPM all 3 servo gears broken, which can't ocurr on the HDE.
		Finally I installed a CPD4 fma co-pilot on the hde; it does not work on a ccpm.
		With eCCPM the servos are connected directly to the swashplate, with HDE the servos are setup in a mechanical mixer using twice the number of linkages.
	www.rcuniverse.com /forum/fb.asp?m=3566734 (1147 words)

	FedoraForum.org - Which SATA-RAID-Controller should I choose?
		hde: 234441648 sectors (120034 MB) w/8192KiB Cache, CHS=16383/255/63
		I googled for almost a day yesterday from scratch and found some info.
		I get this same behavior with an MSI mobo using the VT8237 SouthBridge with a VT6420 SATA controller.
	www.fedoraforum.org /forum/printthread.php?t=2754 (1430 words)

	Bloomberg.com: Germany
		Sept. 16 (Bloomberg) -- The HDE association of German retailers cut its forecast for 2004 and now expects industry sales to fall for a third straight year as reticence among consumers in Europe's largest economy erodes revenue.
		Industry sales will decline 0.5 percent this year, compared with a previous forecast of a 0.5 percent increase, HDE said in a statement posted on its Web site.
		German retailers such as KarstadtQuelle AG have seen sales decline as unemployment hovers at a record of more than 10 percent and Chancellor Gerhard Schroeder's government proposes cuts in welfare spending to spark growth.
	quote.bloomberg.com /apps/news?pid=10000100&sid=aBhkBSRQpW6I&refer=germany (247 words)

	[SM-Discuss] SATA drives
		hde: WDC WD360GD-00FNA0, ATA DISK drive blk: queue c02f31c8, I/O limit 4095Mb (mask 0xffffffff) hdg: no response (status = 0xfe) ide0 at 0x1f0-0x1f7,0x3f6 on irq 14 ide1 at 0x170-0x177,0x376 on irq 15 ide2 at 0xe0838080-0xe0838087,0xe083808a on irq 11 hda: attached ide-disk driver.
		hde: host protected area => 1 hde: 72303840 sectors (37020 MB) w/8192KiB Cache, CHS=4500/255/63, UDMA(133) hdd: attached ide-scsi driver.
		The only other possibility I can think of is something isn't set right in the kernel config.
	lists.ibiblio.org /pipermail/sm-discuss/2003-September/004485.html (366 words)

	Metahuman Science
		It should be noted that in practice 'scientific laws' are not applied in isolation but in conjunction with auxiliary statements or boundary conditions, and these relate to the contextual simplifying assumptions we mentioned earlier.
		This is all fine as far as it goes, but for metascience we need to add a bit more, what we can call the 'hypothetico-deductive-evaluative (HDE) method'.
		These additions relate to how our scientific theories correspond to metahuman goals, in other words how do they help us to enhance our positive actions and reduce negative ones, and are they the best ones that can be used for this purpose.
	www.calresco.org /lucas/science.htm (6216 words)

	BOSTON SCIENTIFIC GETS HDE FOR WINGSPAN SYSTEM (Site not responding. Last check: 2007-10-13)
		The FDA has granted humanitarian device exemption (HDE) approval for Boston Scientific's Wingspan Stent System with Gateway PTA Balloon Catheter for the treatment of atherosclerotic lesions or accumulated plaque in brain arteries.
		The Wingspan Stent System is a self-expanding, nitinol stent sheathed in a delivery system that enables it to reach and open narrowed arteries in the brain.
		Boston Scientific is planning additional studies to evaluate the product's performance after launch.
	www.fdanews.com /dailies/device/2_158/news/44598-1.html (139 words)

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