Technology assessment of medical devices at the center for devices and radiological health

American Journal of Managed Care

Volumn 4, Issue SPEC. ISS. SEPT., 1998, Pages

  Kessler, Larry ^a,b   Richter, Kimber ^a  

^a Ctr Devices and Radiological Hlth   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; COST EFFECTIVENESS ANALYSIS; DEVICE; HEALTH CARE; MARKETING; PRIORITY JOURNAL; RADIOLOGY; REVIEW; RISK ASSESSMENT; SAFETY;

DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; TECHNOLOGY ASSESSMENT, BIOMEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 7844242876     PISSN: 10880224     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (14)

1. Medical Device Amendments of 1976. Pub L No. 94-295, 90 Stat 539 (1976).
2. Federal Food, Drug, and Cosmetic Act of 1938. Pub L No. 75-717, 52 Stat 1040 (1938), as amended 21 USC §301 et seq (1988).
3. Safe Medical Devices Act of 1990. Pub L No. 101-629, 104 Stat 4511 (1990).
4. FDA Modernization Act. Pub L No. 105-115, 111 Stat 2296 (1997).
5. Moss AJ, Hall WJ, Cannom DS, et al, for the Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med 1996;335:1933-1940.
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10. Blum DY. Untoward events associated with use of midterm I.V. devices. J Intraven Nurs 1995;18:116-119.
11. Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med 1995;123:841-844.
12. Maki D. Reactions associated with midline catheters for intravenous access [editorial]. Ann Intern Med 1995;123: 884-886.
13. Connors AF Jr, Speroff T, Dawson NV, et al, for the SUPPORT Investigators. The effectiveness of right heart catheterization in the initial care of critically ill patients. JAMA 1996;276:889-889.
14. Dalen JE, Bone RC. Is it time to pull the pulmonary artery catheter? [editorial]. JAMA 1996;276:916-918.