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Items: 1 to 20 of 670

1.

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.

PMID:
19564262
2.

Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions.

Dolcimascolo F.

J Cardiovasc Transl Res. 2009 Jun;2(2):147-9. doi: 10.1007/s12265-009-9100-2. Epub 2009 Mar 13.

PMID:
20559980
3.

Mechanical devices and US Food and Drug Administration (FDA) approval.

Reitz BA.

Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2006:123-7. Review.

PMID:
16638557
4.

Medical device regulation: an introduction for the practicing physician.

Maisel WH.

Ann Intern Med. 2004 Feb 17;140(4):296-302. Review.

PMID:
14970153
5.

Postmarket evaluation of breakthrough technologies.

Rao SV, Califf RM, Kramer JM, Peterson ED, Gross TP, Pepine CJ, Williams DO, Donohoe D, Waksman R, Mehran R, Krucoff MW.

Am Heart J. 2008 Aug;156(2):201-8. doi: 10.1016/j.ahj.2008.01.036.

PMID:
18657647
6.
7.

Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States: executive summary.

Acker MA, Pagani FD, Stough WG, Mann DL, Jessup M, Kormos R, Slaughter MS, Baldwin T, Stevenson L, Aaronson KD, Miller L, Naftel D, Yancy C, Rogers J, Teuteberg J, Starling RC, Griffith B, Boyce S, Westaby S, Blume E, Wearden P, Higgins R, Mack M.

Ann Thorac Surg. 2012 Dec;94(6):e163-8. doi: 10.1016/j.athoracsur.2012.09.041. Epub 2012 Nov 12. Review.

PMID:
23153480
8.

Making sense of the food and drug administration.

Connor JA.

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

PMID:
17055960
9.

Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.

Acker MA, Pagani FD, Stough WG, Mann DL, Jessup M, Kormos R, Slaughter MS, Baldwin T, Stevenson L, Aaronson KD, Miller L, Naftel D, Yancy C, Rogers J, Teuteberg J, Starling RC, Griffith B, Boyce S, Westaby S, Blume E, Wearden P, Higgins R, Mack M.

Ann Thorac Surg. 2012 Dec;94(6):2147-58. doi: 10.1016/j.athoracsur.2012.09.040. Epub 2012 Nov 12. Review.

PMID:
23153481
10.

The Food and Drug Administration and atrial defibrillation devices.

Chen L, Keane AT, Every NR.

Am J Manag Care. 1999 Jul;5(7):899-909.

11.

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
12.

Challenges in regulating breakthrough medical devices.

Muni NI, Gross TP, Boam AB, Wang S, Zuckerman BD.

Food Drug Law J. 2005;60(2):137-42. No abstract available.

PMID:
16097092
13.

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
14.

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
15.

Pediatric circulatory support: an FDA perspective.

Rinaldi JE, Chen EA, Berman MR.

ASAIO J. 2005 Sep-Oct;51(5):533-5.

PMID:
16322713
16.

Developing, regulating, and ethically evaluating new technologies in otolaryngology-head and neck surgery.

Orlandi RR, Marple BF.

Otolaryngol Clin North Am. 2009 Oct;42(5):739-45, vii. doi: 10.1016/j.otc.2009.07.007.

PMID:
19909854
17.

Food and Drug Administration regulation of in vitro diagnostic devices.

Mansfield E, O'Leary TJ, Gutman SI.

J Mol Diagn. 2005 Feb;7(1):2-7. Review.

18.

Improving medical device regulation: the United States and Europe in perspective.

Sorenson C, Drummond M.

Milbank Q. 2014 Mar;92(1):114-50. doi: 10.1111/1468-0009.12043.

19.

Safety valve may reduce adverse events during open-heart surgery.

Ankney RN, Kolff J, Loeffler K.

J Healthc Risk Manag. 1997 Spring;17(2):12-8. No abstract available.

PMID:
10173138
20.

The critical path to medical innovation.

Williams D.

Med Device Technol. 2004 Jun;15(5):8-10.

PMID:
15285478

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