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Items: 17

1.

Inclusion of training patients in US Food and Drug Administration premarket approval cardiovascular device studies.

Chen CE, Dhruva SS, Bero LA, Redberg RF.

Arch Intern Med. 2011 Mar 28;171(6):534-9. doi: 10.1001/archinternmed.2010.445.

PMID:
21098342
2.

Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.

Dhruva SS, Bero LA, Redberg RF.

Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):165-71. doi: 10.1161/CIRCOUTCOMES.110.958215. Review.

3.

Technology transfer of neuroprosthetic devices.

Peckham PH, Thrope G, Woloszko J, Habasevich R, Scherer M, Kantor C.

J Rehabil Res Dev. 1996 Apr;33(2):173-83. Review.

PMID:
8724172
4.

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

Saviola J.

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

PMID:
15876645
5.

Making sense of the food and drug administration.

Connor JA.

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

PMID:
17055960
6.

Orthopedic implant approval: achieving the right balance.

Zywiel MG, Mont MA.

Expert Rev Med Devices. 2011 Jul;8(4):405-8. doi: 10.1586/erd.11.38. Review. No abstract available.

PMID:
21728724
7.
9.

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
10.

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.

11.

Medical device regulation: an introduction for the practicing physician.

Maisel WH.

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

PMID:
14970153
13.

A US Food and Drug Administration perspective on cardiac resynchronization and ventricular assist device trials.

Faris O, Chen E, Berman M, Moynahan M, Zuckerman B.

Congest Heart Fail. 2005 Jul-Aug;11(4):207-11. Review.

14.

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
15.

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
16.

Evaluating devices for treating epilepsy.

Litt B.

Epilepsia. 2003;44 Suppl 7:30-7. Review.

17.

Barriers to cardiovascular device innovation in Europe.

Pinto F, Fraser AG, Kautzner J, Kreutzer K, Piat S, Siebert M, Vardas P, Windecker S; Cardiovascular Round Table (CRT)..

Eur Heart J. 2016 Jan 7;37(2):140-4. doi: 10.1093/eurheartj/ehv275. Review. No abstract available.

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