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Items: 1 to 20 of 45

1.

Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

Feldman MD, Petersen AJ, Karliner LS, Tice JA.

J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63. doi: 10.1007/s11606-007-0275-4. Review.

2.

Medical device regulation: an introduction for the practicing physician.

Maisel WH.

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

PMID:
14970153
3.

Left to their own devices: breakdowns in United States medical device premarket review.

Hines JZ, Lurie P, Yu E, Wolfe S.

PLoS Med. 2010 Jul 13;7(7):e1000280. doi: 10.1371/journal.pmed.1000280. Review. No abstract available.

5.

Making sense of the food and drug administration.

Connor JA.

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

PMID:
17055960
6.

The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?

Fargen KM, Frei D, Fiorella D, McDougall CG, Myers PM, Hirsch JA, Mocco J.

J Neurointerv Surg. 2013 Jul;5(4):269-75. doi: 10.1136/neurintsurg-2012-010400. Epub 2012 Jul 4. Review. No abstract available.

PMID:
22764203
7.

Medical and dental technology assessment.

Ballard GT.

Technol Health Care. 1996 Sep;4(3):291-303. Review.

PMID:
8931239
8.

Critical assessment of new devices.

Hamilton C.

Perfusion. 2007 May;22(3):167-71. Review.

PMID:
18018395
9.

Medical device specificities: opportunities for a dedicated product development methodology.

Santos IC, Gazelle GS, Rocha LA, Tavares JM.

Expert Rev Med Devices. 2012 May;9(3):299-311. doi: 10.1586/erd.12.3. Review.

PMID:
22702261
10.

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
11.

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
12.

The nurse's role in contributing to new device development.

Weir H, Grocott P, Ram MB.

Nurs Times. 2006 Jun 27-Jul 3;102(26):36-9. Review.

PMID:
16845815
13.

[Clinical trials with medical devices: lack of quality illustrated for faecal incontinence].

Vonthein R, Hemmelmann C, König IR, Schwandner T, Bruch HP, Ziegler A.

Zentralbl Chir. 2012 Aug;137(4):380-4. doi: 10.1055/s-0031-1271549. Epub 2011 Jul 7. Review. German.

PMID:
21739411
14.

[Industry regulation and its relationship to the rapid marketing of medical devices].

Matsuoka A.

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2012;(130):13-20. Review. Japanese.

PMID:
23243983
15.

[Role of patient safety in the official approval of new surgical techniques and devices].

Baranyai Z, Jósa V, Kulin L.

Orv Hetil. 2011 Dec 25;152(52):2091-5. doi: 10.1556/OH.2011.29279. Review. Hungarian.

PMID:
22155517
16.

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Tarricone R, Torbica A, Ferré F, Drummond M.

Expert Rev Pharmacoecon Outcomes Res. 2014 Oct;14(5):707-18. doi: 10.1586/14737167.2014.950233. Epub 2014 Sep 8. Review.

PMID:
25196848
17.

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
18.

Medical devices: US medical device regulation.

Jarow JP, Baxley JH.

Urol Oncol. 2015 Mar;33(3):128-32. doi: 10.1016/j.urolonc.2014.10.004. Epub 2014 Nov 6. Review.

PMID:
25458071
19.

A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe.

Campillo-Artero C.

Health Policy. 2013 Nov;113(1-2):38-44. doi: 10.1016/j.healthpol.2013.03.017. Epub 2013 Apr 17. Review.

PMID:
23602548
20.

How does medical device regulation perform in the United States and the European union? A systematic review.

Kramer DB, Xu S, Kesselheim AS.

PLoS Med. 2012;9(7):e1001276. doi: 10.1371/journal.pmed.1001276. Epub 2012 Jul 31. Review.

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