Commentary: Evaluating and regulating device therapy

BMJ

Volumn 342, Issue 7807, 2011, Pages

  Freemantle, Nick ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIAC RESYNCHRONIZATION THERAPY DEVICE; DEFIBRILLATOR; DEVICE SAFETY; DEVICE THERAPY; HEART FAILURE; HUMAN; MORBIDITY; MORTALITY; NOTE; PACEMAKER; PRIORITY JOURNAL; PROSTHESIS; QUALITY OF LIFE; RISK BENEFIT ANALYSIS; STENT; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; DEVICE APPROVAL; EUROPEAN UNION; HEALTH CARE COST; LEGAL ASPECT; STANDARD;

DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EUROPEAN UNION; HEALTH CARE SECTOR;

EID: 79956333887     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.d2839     Document Type: Note

References (9)

1. FDA. Medical devices. Premarket Approval (PMA). www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ PremarketSubmissions/PremarketApprovalPMA/default.htm.
2. FDA. Statistical guidance for clinical trials of non diagnostic medical devices. 1996. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm106757.htm.
3. MHRA. Guidance notes for manufacturers on statistical considerations for clinical investigations of medical devices. www.mhra.gov.uk/home/idcplg? IdcService=GET-FILE&dDocName=CON007518&RevisionSelectionMethod= Latest&noSaveAs=0&Rendition=WEB
4. MHRA. The CE mark. 2011. www.mhra.gov.uk/home/groups/es-era/documents/ publication/con007490.pdf
5. European Medicines Agency. ICH harmonised tripartite guideline: statistical principles for clinical trials E9. 1998. www.ema.europa.eu/pdfs/ human/ich/036396en.pdf.
6. Bradley DJ, Bradley EA, Baughman KL, Berger RD, Calkins H, Goodman SN, et al. Cardiac resynchronization and death from progressive heart failure. A meta analysis of randomized controlled trials. JAMA 2003;289:730-40.
7. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-37. (Pubitemid 40110811)
8. Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar OH, Tillman DB, et al. Pacemaker and ICD generator malfunctions. Analysis of Food and Drug Administration annual reports. JAMA 2006;295:1901-6.
9. Gould PA, Krahn AD. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006;295:1907-11