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Results: 1 to 20 of 144

Similar articles for PubMed (Select 20869626)

1.

Interventional cardiology live case presentations regulatory considerations.

Farb A, Brown SA, Wolf DA, Zuckerman B.

Heart Rhythm. 2010 Oct;7(10):e1-3. doi: 10.1016/j.hrthm.2010.08.024.

PMID:
20869626
2.

Interventional cardiology live case presentations: regulatory considerations.

Farb A, Brown SA, Wolf DA, Zuckerman B.

Catheter Cardiovasc Interv. 2010 Oct 1;76(4):E126-9. doi: 10.1002/ccd.22718.

PMID:
20862708
3.

Interventional cardiology live case presentations: regulatory considerations.

Farb A, Brown SA, Wolf DA, Zuckerman B.

J Am Coll Cardiol. 2010 Oct 5;56(15):1283-5. doi: 10.1016/j.jacc.2010.08.601. No abstract available.

4.

FDA's perspectives on cardiovascular devices.

Chen EA, Patel-Raman SM, O'Callaghan K, Hillebrenner MG.

J Cardiovasc Transl Res. 2009 Jun;2(2):143-6. doi: 10.1007/s12265-009-9096-7. Epub 2009 Mar 10. Review.

PMID:
20559979
5.

The FDA's role in medical device clinical studies of human subjects.

Saviola J.

J Neural Eng. 2005 Mar;2(1):S1-4. Epub 2005 Feb 22. Review.

PMID:
15876645
6.

Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.

Beekman RH 3rd, Duncan BW, Hagler DJ, Jones TK, Kugler JD, Moore JW, Jenkins KJ; Workgroup on Pediatric Cardiac Devices, Section on Cardiology and Cardiac Surgery, American Academy of Pediatrics.

Pediatrics. 2009 Jul;124(1):e155-62. doi: 10.1542/peds.2008-3726.

7.

FDA medical device approval: things you didn't learn in medical school or residency.

Buch B.

Am J Orthop (Belle Mead NJ). 2007 Aug;36(8):407-12.

PMID:
17849025
8.

A program to provide regulatory support for investigator-initiated clinical research.

Arbit HM, Paller MS.

Acad Med. 2006 Feb;81(2):146-53.

PMID:
16436575
9.

Technology assessment of medical devices at the Center for Devices and Radiological Health.

Kessler L, Richter K.

Am J Manag Care. 1998 Sep 25;4 Spec No:SP129-35.

10.

U.S. FDA rules for device investigations.

Munzner R.

IEEE Eng Med Biol Mag. 2003 Jan-Feb;22(1):95-6. No abstract available.

PMID:
12683070
12.

When informed consent is not required in studies.

Maloney DM.

Hum Res Rep. 2006 Jun;21(6):3. No abstract available.

PMID:
17111532
13.

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

Ashar BS, Dang JM, Krause D, Luke MC.

Hernia. 2011 Dec;15(6):603-5. doi: 10.1007/s10029-011-0872-3. Epub 2011 Sep 11. Review.

PMID:
21909977
14.

Differences in the approval process for interventional devices in Europe and USA: IN MEDIO STAT VIRTUS.

Di Mario C.

EuroIntervention. 2011 Mar;6(8):913, 915-7. doi: 10.4244/EIJV6I8A159. No abstract available.

15.

Successful recruitment for medical device clinical studies.

Donawa M.

Med Device Technol. 2004 Oct;15(8):25-7.

PMID:
16225270
17.

An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

Peña C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, Stevens T.

IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):421-4. Review.

PMID:
17894274
18.

Medical devices; investigational device exemptions--FDA. Final rule.

[No authors listed]

Fed Regist. 1998 Nov 23;63(225):64617-26.

PMID:
10338870
19.

Access to clinical devices through nontraditional routes.

Klepinski RJ.

Food Drug Law J. 2007;62(4):849-63. No abstract available.

PMID:
18557233
20.

Medical devices; investigational device exemptions--FDA. Proposed rule.

[No authors listed]

Fed Regist. 1998 Jul 15;63(135):38131-8.

PMID:
10181246
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