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Items: 1 to 20 of 26

1.

FDA regulation of cardiovascular devices and opportunities for improvement.

Dhruva SS, Redberg RF.

J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. doi: 10.1007/s10840-012-9767-1. Epub 2012 Dec 21.

PMID:
23263896
2.

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
3.

Approval of high-risk medical devices in the US: implications for clinical cardiology.

Rome BN, Kramer DB, Kesselheim AS.

Curr Cardiol Rep. 2014;16(6):489. doi: 10.1007/s11886-014-0489-0. Review.

4.

Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort.

Hampton D, Green JA, Robboy M, Eydelman M.

Eye Contact Lens. 2017 Jan;43(1):2-4. doi: 10.1097/ICL.0000000000000324. Review.

PMID:
27941360
5.

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
6.
7.

Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.

Day CS, Park DJ, Rozenshteyn FS, Owusu-Sarpong N, Gonzalez A.

J Bone Joint Surg Am. 2016 Mar 16;98(6):517-24. doi: 10.2106/JBJS.15.00286. Review.

PMID:
26984921
8.

FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.

Welle C, Krauthamer V.

IEEE Pulse. 2012 Mar;3(2):37-41. doi: 10.1109/MPUL.2011.2181022. Review.

PMID:
22481744
9.

Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?

Weinberger J, Rundback JH, Ratchford EV.

Am J Ther. 2005 Mar-Apr;12(2):186-91. Review.

PMID:
15767839
10.

Current challenges for clinical trials of cardiovascular medical devices.

Zannad F, Stough WG, Piña IL, Mehran R, Abraham WT, Anker SD, De Ferrari GM, Farb A, Geller NL, Kieval RS, Linde C, Redberg RF, Stein K, Vincent A, Woehrle H, Pocock SJ.

Int J Cardiol. 2014 Jul 15;175(1):30-7. doi: 10.1016/j.ijcard.2014.05.021. Epub 2014 May 16. Review.

PMID:
24861254
11.

Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.

Dhruva SS, Bero LA, Redberg RF.

JAMA. 2009 Dec 23;302(24):2679-85. doi: 10.1001/jama.2009.1899. Review. Erratum in: JAMA. 2010 Feb 3;303(5):422.

PMID:
20040556
12.

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
13.

Impact of expanding indications on the safety of pacemakers and defibrillators.

Maisel WH; American Cardiology College; American Heart Association; North American Society of Pacing and Electrophysiology (NASPE).

Card Electrophysiol Rev. 2003 Jan;7(1):30-2. Review.

PMID:
12766513
14.

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

Bates KE, Vetter VL, Li JS, Cummins S, Aguel F, Almond C, Dubin AM, Elia J, Finkle J, Hausner EA, Joseph F, Karkowsky AM, Killeen M, Lemacks J, Mathis L, McMahon AW, Pinnow E, Rodriguez I, Stockbridge NL, Stockwell M, Tassinari M, Krucoff MW.

Am Heart J. 2012 Oct;164(4):481-92. doi: 10.1016/j.ahj.2012.07.019.

PMID:
23067905
16.

The FDA process for the evaluation and approval of orthopaedic devices.

Kirkpatrick JS, Stevens T.

J Am Acad Orthop Surg. 2008 May;16(5):260-7. Review.

PMID:
18460686
17.

The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

ASGE Technology Committee, Diehl DL, Tierney WM, Adler DG, Conway JD, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Mamula P, Pedrosa MC, Rodriguez SA.

Gastrointest Endosc. 2010 Jul;72(1):5-10. doi: 10.1016/j.gie.2010.01.024. Epub 2010 Apr 24. Review.

PMID:
20421100
18.

FDA Policy and Cardiovascular Medicine.

Ross JS, Kesselheim AS.

Circulation. 2015 Sep 22;132(12):1136-45. doi: 10.1161/CIRCULATIONAHA.114.010295. Review. No abstract available.

19.

Making sense of the food and drug administration.

Connor JA.

Semin Pediatr Surg. 2006 Nov;15(4):293-301. Review.

PMID:
17055960
20.

U.S. Food and Drug Administration and off-label use of expandable metal biliary stents within the peripheral vasculature.

Yustein AS, Schultz D, Neuland C, Buckles DS, Nipper JC, Stephenson RA, Gonzalez G.

J Vasc Interv Radiol. 2008 Jul;19(7):965-9. Review.

PMID:
18672491

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