Similar articles for PMID: 15082674

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1

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

Deyo RA. Deyo RA. J Am Board Fam Pract. 2004 Mar-Apr;17(2):142-9. doi: 10.3122/jabfm.17.2.142. J Am Board Fam Pract. 2004. PMID: 15082674 Free article.

2

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. Peña C, et al. IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):421-4. doi: 10.1109/TNSRE.2007.903973. IEEE Trans Neural Syst Rehabil Eng. 2007. PMID: 17894274 Review.

3

Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.

Zhang AD, Schwartz JL, Ross JS. Zhang AD, et al. Milbank Q. 2019 Sep;97(3):796-819. doi: 10.1111/1468-0009.12403. Epub 2019 Jul 14. Milbank Q. 2019. PMID: 31304643 Free PMC article.

4

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

Ronquillo JG, Zuckerman DM. Ronquillo JG, et al. Milbank Q. 2017 Sep;95(3):535-553. doi: 10.1111/1468-0009.12278. Milbank Q. 2017. PMID: 28895231 Free PMC article.

5

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

Kirkpatrick JS, Stevens T. Kirkpatrick JS, et al. J Am Acad Orthop Surg. 2008 May;16(5):260-7. doi: 10.5435/00124635-200805000-00004. J Am Acad Orthop Surg. 2008. PMID: 18460686 Review.

6

New technology in electrophysiology: FDA process and perspective.

Selzman KA, Fellman M, Farb A, de Del Castillo S, Zuckerman B. Selzman KA, et al. J Interv Card Electrophysiol. 2016 Oct;47(1):11-18. doi: 10.1007/s10840-016-0127-4. Epub 2016 Mar 28. J Interv Card Electrophysiol. 2016. PMID: 27020440 Review.

7

The impact of FDA reform.

Trunzo J. Trunzo J. Med Device Technol. 2003 Apr;14(3):36-7. Med Device Technol. 2003. PMID: 12789699

8

Administrative practices and procedures; internal review of agency decisions---FDA. Direct final rule.

[No authors listed] [No authors listed] Fed Regist. 1998 Jun 16;63(115):32733-5. Fed Regist. 1998. PMID: 10180278

9

Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.

Basile EM, Tolomeo D, Gluck E. Basile EM, et al. Food Drug Law J. 2009;64(1):149-69. Food Drug Law J. 2009. PMID: 19998744

10

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel AM, Rathi VK, Grauer JN, Ross JS. Samuel AM, et al. Clin Orthop Relat Res. 2016 Apr;474(4):1053-68. doi: 10.1007/s11999-015-4634-x. Epub 2015 Nov 19. Clin Orthop Relat Res. 2016. PMID: 26584802 Free PMC article.

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