Enrollment and monitoring of women in post-approval studies for medical devices mandated by the food and drug administration

Journal of Women's Health

Volumn 23, Issue 3, 2014, Pages 218-223

  Pinnow, Ellen ^a   Herz, Naomi ^a   Loyo Berrios, Nilsa ^a   Tarver, Michelle ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CARDIOVASCULAR EQUIPMENT; CLINICAL STUDY; DENTAL DEVICE; DEVICE APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; MEDICAL DEVICE; MULTIVARIATE ANALYSIS; OPHTHALMOLOGICAL EQUIPMENT; ORTHOPEDIC EQUIPMENT; PACEMAKER; PRIORITY JOURNAL; SEPTAL OCCLUDER; SEX DIFFERENCE; SURGICAL EQUIPMENT;

ADULT; DEVICE APPROVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PATIENT PARTICIPATION; PATIENT SELECTION; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; SELECTION BIAS; SEX FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896116170     PISSN: 15409996     EISSN: 1931843X     Source Type: Journal    
DOI: 10.1089/jwh.2013.4343     Document Type: Article

References (23)

1. Institute of Medicine, Committee on Understanding the Biology of Sex and Gender Differences. Exploring the biological contributions to human health: Does sex matter? Washington, DC: National Academy of Sciences, 2001.
2. Kim C, Redberg RF, Pavlic T, Eagle KA. A systematic review of gender differences in mortality after coronary artery bypass graft surgery and percutaneous coronary interventions. Clin Cardiol 2007;30:491-495.
3. Lansky AJ, Hochman JS, Ward PA, et al. Percutaneous coronary intervention and adjunctive pharmacotherapy in women: A statement for healthcare professionals from the American Heart Association. Circulation 2005;111:940- 953.
4. Tavris DR, Dey S, Albrecht-Gallauresi B, Brindis RG, Shaw R, Weintraub W, Mitchel K. Risk of local adverse events following cardiac catheterization by hemostasis device use-phase II. J Invasive Cardiol 2005;17::644-650.
5. Tavris DR, Gallauresi BA, Dey S, Brindis R, Mitchel K. Risk of local adverse events by gender following cardiac catheterization. Pharmacoepidemiol Drug Saf 2007;16: 125-131.
6. Tavris DR, Gallauresi B, Rich S, Bell C. Relative risks of reported serious injury and death associated with hemostasis devices by gender. Pharmacoepidemiol Drug Saf 2003;12:237-241.
7. Inacio MC, Ake CF, Paxton EW, Khatod M, Wang C, Gross TP, Kaczmarek RG, Marinac-Dabic D, Sedrakyan A. Sex and risk of hip implant failure: Assessing total hip arthroplasty outcomes in the United States. JAMA Intern Med 2013;173:435-441.
8. Freeman JV, Masoudi FA. Effectiveness of implantable cardioverter defibrillators and cardiac resynchronization therapy in heart failure. Heart Fail Clin 2013;9:59-77.
9. Arshad A, Moss AJ, Foster E, et al. Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) Trial. J Am Coll Cardiol 2011;57:813- 820.
10. Greene KA. Gender-specific design in total knee arthroplasty. J Arthroplasty 2007;27(7 Suppl 3):27-31.
11. O'Connor MI. Implant survival, knee function and pain relief after TKA: Are there differences between men and women? Clin Orthop Relat Res 2011;469:1846-1851.
12. Rand JA, Ilstrup DM. Survivorship analysis of total knee arthroplasty: Cumulative rates of survival of 9200 total knee arthroplasties. J Bone Joint Surg Am 1991;73:397- 409.
13. Food and Drug Administration. Collection, analysis, and availability of demographic subgroups for FDA-approved medical products. Available at: www.fda.gov/Regulatory Information/Legislation/ FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ ucm356316.htm Accessed October 30, 2013.
14. Food and Drug Administration. Procedures for handling post-approval studies imposed by PMA order. Available at www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm070974.htm Accessed July 26, 2012.
15. Code of Federal Regulations. Title 21. Food and Drugs. Avalable at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR = 814.82 Accessed July 26, 2012.
16. Food and Drug Administration. Report on implementation of post-approval studies for medical devices workshop. 2009. Available at: www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/Post ApprovaStudies/UCM208562.pdf Accessed July 26, 2012.
17. Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther 2010;17:2-7.
18. Katz DJ, Stanley JC, Zelenock GB. Gender differences in abdominal aortic aneurysm prevalence, treatment, and outcome. J Vasc Surg 1997;25:561-568.
19. Feldt R, Avasthey P, Yoshimasu F, Kurland L, Titus J. Incidence of congenital heart disease in children born to residents of Olmsted County, Minnesota, 1950-1969. Mayo Clin Proc 1971;46:794-799.
20. American Society for Aesthetic Plastic Surgery (ASAPS). ASAPS cosmetic surgery attitude study shows big gender differences: American Society for Aesthetic Plastic Surgery Reports 2004 survey. Available at: www.surgery.org/media/news-releases/asaps-cosmetic-surgery-attitude-study- showsbig- gender-differences-american-society-for-aesthetic-plastic-s Accessed July 27, 2012.
21. National Institute of Dental and Craniofacial Research. Prevalence of TMJD and its signs and symptoms. Available at: www.nidcr.nih.gov/DataStatistics/ FindDataByTopic/FacialPain/PrevalenceTMJD.htm Accessed July 27, 2012.
22. Food and Drug Administration. Draft guidance for industry and food and drug administration staff: Evaluation of sex differences in medical device clinical studies. Available at: www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm?utm- campaign=Google2&utm-source =fdaSearch&utm-medium= website&utm-term = Evaluation%20of%20Sex%20and% 20Gender%20Differences%20in%20Medical%20Device% 20Clinical%20Studies&utm-content = 1 Accessed June 28, 2012.
23. Food and Drug Administration. Report on implementation of post-approval studies for medical devices workshop. Available at: www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ PostApprovaStudies/UCM208562.pdf Accessed July 27, 2012.