-
1
-
-
0029417611
-
Trends and events in FDA regulation of medical devices over the last fifty years
-
R.R. Munsey Trends and events in FDA regulation of medical devices over the last fifty years Food Drug Law J 50 1995 163 177
-
(1995)
Food Drug Law J
, vol.50
, pp. 163-177
-
-
Munsey, R.R.1
-
2
-
-
33644673977
-
-
Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, Pub. L. No. 94-295, 90 Stat. 539 (1976).
-
Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, Pub. L. No. 94-295, 90 Stat. 539 (1976).
-
-
-
-
3
-
-
1842292768
-
U.S. Food and Drug Administration and regulation of medical devices in radiology
-
W.F. Pritchard, and R.F. Carey U.S. Food and Drug Administration and regulation of medical devices in radiology Radiology 205 1997 27 36
-
(1997)
Radiology
, vol.205
, pp. 27-36
-
-
Pritchard, W.F.1
Carey, R.F.2
-
4
-
-
33644691214
-
-
Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104 Stat. 4511 (1990).
-
Safe Medical Devices Act of 1990, Pub. L. No. 101-629, 104 Stat. 4511 (1990).
-
-
-
-
5
-
-
4243065621
-
Modernizing the FDA: An incremental revolution
-
R.A. Merrill Modernizing the FDA: an incremental revolution Health Aff (Millwood) 18 1999 96 111
-
(1999)
Health Aff (Millwood)
, vol.18
, pp. 96-111
-
-
Merrill, R.A.1
-
6
-
-
7844242876
-
Technology assessment of medical devices at the Center for Devices and Radiological Health
-
L. Kessler, and K. Richter Technology assessment of medical devices at the Center for Devices and Radiological Health Am J Manag Care 1998 4 Spec no:SP129-35
-
(1998)
Am J Manag Care
, pp. 4
-
-
Kessler, L.1
Richter, K.2
-
7
-
-
0029151383
-
Radiographic detection of strut separations in Bjork-Shiley convexo-concave mitral valves
-
W.W. O'Neill, J.G. Chandler, and R.E. Gordon Radiographic detection of strut separations in Bjork-Shiley convexo-concave mitral valves N Engl J Med 333 1995 414 419
-
(1995)
N Engl J Med
, vol.333
, pp. 414-419
-
-
O'Neill, W.W.1
Chandler, J.G.2
Gordon, R.E.3
-
8
-
-
0342547032
-
Infusion pump adverse events: Experience from medical device reports
-
S.L. Brown, A.E. Morrison, C.M. Parmentier, E.K. Woo, and R.L. Vishnavujjala Infusion pump adverse events: experience from medical device reports J Intraven Nurs 20 1997 41 49
-
(1997)
J Intraven Nurs
, vol.20
, pp. 41-49
-
-
Brown, S.L.1
Morrison, A.E.2
Parmentier, C.M.3
Woo, E.K.4
Vishnavujjala, R.L.5
-
9
-
-
0035522807
-
Dental Device-associated problems: An analysis of FDA postmarket surveillance data
-
J. Fuller, and C. Parmentier Dental Device-associated problems: an analysis of FDA postmarket surveillance data J Am Dent Assoc 132 2001 1540 1548
-
(2001)
J Am Dent Assoc
, vol.132
, pp. 1540-1548
-
-
Fuller, J.1
Parmentier, C.2
-
10
-
-
0031733770
-
Improving Patient care by reporting problems with medical devices
-
G.G. White, M.D. Weick-Brady, and S.A. Goldman Improving Patient care by reporting problems with medical devices CRNA 9 1998 139 156
-
(1998)
CRNA
, vol.9
, pp. 139-156
-
-
White, G.G.1
Weick-Brady, M.D.2
Goldman, S.A.3
-
11
-
-
0035314987
-
Medical device adverse events and the temporary invasive cardiac pacemaker
-
D. Dwyer Medical device adverse events and the temporary invasive cardiac pacemaker Int J Trauma Nurs 7 2001 70 73
-
(2001)
Int J Trauma Nurs
, vol.7
, pp. 70-73
-
-
Dwyer, D.1
-
12
-
-
0036633471
-
Health effects associated with medical glove use
-
S.F. Dillard, B. Hefflin, R.G. Kaczmarek, E.L. Petsonk, and T.P. Gross Health effects associated with medical glove use AORN J 76 2002 88 96
-
(2002)
AORN J
, vol.76
, pp. 88-96
-
-
Dillard, S.F.1
Hefflin, B.2
Kaczmarek, R.G.3
Petsonk, E.L.4
Gross, T.P.5
-
13
-
-
0036673128
-
An association of silicone-gel breast implant rupture and fibromyalgia
-
S.L. Brown, H.J. Duggirala, and G. Pennello An association of silicone-gel breast implant rupture and fibromyalgia Curr Rheumatol Rep 4 2002 293 298
-
(2002)
Curr Rheumatol Rep
, vol.4
, pp. 293-298
-
-
Brown, S.L.1
Duggirala, H.J.2
Pennello, G.3
-
14
-
-
0030819041
-
Primer on medical device regulation. Part I. History and background
-
L.H. Monsein Primer on medical device regulation. Part I. History and background Radiology 205 1997 1 9
-
(1997)
Radiology
, vol.205
, pp. 1-9
-
-
Monsein, L.H.1
-
15
-
-
33749046020
-
Improving patient care by reporting problems with medical devices
-
Rockville, MD: Department of Health and Human Services, U.S. Food and Drug Administration, HF-2; September
-
Improving patient care by reporting problems with medical devices. Med Watch. Rockville, MD: Department of Health and Human Services, U.S. Food and Drug Administration, HF-2; September 1997.
-
(1997)
Med Watch
-
-
-
16
-
-
33644693076
-
-
Center for Devices and Radiologic Health. Available from: http://www.fda.gov/cdrh/index.html/. Accessed January 18, 2005.
-
-
-
-
18
-
-
0026431943
-
Use of selected medical device implants in the Unites States, 1988
-
Hyattsville, MD: National Center for Health Statistics, 26 February
-
Moss AJ, Hamburger S, Moore RM, Jeng LL, Howie LJ. Use of selected medical device implants in the Unites States, 1988. Advance Data from Vital and Health Statistics of the National Center for Health Statistics 191:1-24 Hyattsville, MD: National Center for Health Statistics, 26 February 1991.
-
(1991)
Advance Data from Vital and Health Statistics of the National Center for Health Statistics
, vol.191
, pp. 1-24
-
-
Moss, A.J.1
Hamburger, S.2
Moore, R.M.3
Jeng, L.L.4
Howie, L.J.5
-
19
-
-
0003444414
-
-
Report to the FDA Commissioner from the Task Force on Risk Management. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; May
-
Managing Risks from Medical Product Use: Creating a Risk Management Framework. Report to the FDA Commissioner from the Task Force on Risk Management. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; May 1999.
-
(1999)
Managing Risks from Medical Product Use: Creating a Risk Management Framework
-
-
-
20
-
-
0030762245
-
Primer on medical device regulation. Part II. Regulation of medical devices by the U.S. Food and Drug Administration
-
L.H. Monsein Primer on medical device regulation. Part II. Regulation of medical devices by the U.S. Food and Drug Administration Radiology 205 1997 10 18
-
(1997)
Radiology
, vol.205
, pp. 10-18
-
-
Monsein, L.H.1
-
21
-
-
1042288296
-
Medical device regulation: An introduction for the practicing physician
-
W.H. Maisel Medical device regulation: an introduction for the practicing physician Ann Intern Med 140 2004 296 302
-
(2004)
Ann Intern Med
, vol.140
, pp. 296-302
-
-
Maisel, W.H.1
-
22
-
-
1042294545
-
Medical device and user facility and manufacturer reporting, certification and registration; Delegations of authority; Medical device reporting procedures; Final rules
-
Medical device and user facility and manufacturer reporting, certification and registration; delegations of authority; medical device reporting procedures; final rules Fed Regist 60 1995 63577 63606
-
(1995)
Fed Regist
, vol.60
, pp. 63577-63606
-
-
-
23
-
-
0037030819
-
Postmarket surveillance. Final rule
-
Postmarket surveillance. Final rule Fed Regist 67 2002 5943 5952
-
(2002)
Fed Regist
, vol.67
, pp. 5943-5952
-
-
-
25
-
-
33644697518
-
-
Report to the FDA Commissioner from the Task Force on Risk Management. Rockville, MD: U.S. Department of Health 26. 105 Code of Massachusetts Regulations: Department of Public Health.
-
Managing Risks from Medical Product Use: Creating a Risk Management Framework. Report to the FDA Commissioner from the Task Force on Risk Management. Rockville, MD: U.S. Department of Health 26. 105 Code of Massachusetts Regulations: Department of Public Health. 2001. 130.1201-130.130.
-
(2001)
Managing Risks from Medical Product Use: Creating a Risk Management Framework
-
-
-
26
-
-
0035195534
-
ACC key data elements and data definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes: A report of the American College of Cardiology Task Force on Clinical Data Standards
-
C.P. Cannon, A. Battler, R.G. Brindis, L.J. Cox, S.G. Ellis, and N.R. Every ACC key data elements and data definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes: a report of the American College of Cardiology Task Force on Clinical Data Standards J Am Coll Cardiol 38 2001 2114 2130
-
(2001)
J Am Coll Cardiol
, vol.38
, pp. 2114-2130
-
-
Cannon, C.P.1
Battler, A.2
Brindis, R.G.3
Cox, L.J.4
Ellis, S.G.5
Every, N.R.6
-
27
-
-
33644667942
-
-
New York Pub. Health L. No. 2805-1 Incident Reporting (added L. 1986, c.266).
-
New York Pub. Health L. No. 2805-1 Incident Reporting (added L. 1986, c.266).
-
-
-
-
28
-
-
0005879743
-
Statistical process control for continuous forest products manufacturing operations
-
D.F. Cook Statistical process control for continuous forest products manufacturing operations Forest Prod J 42 1992 47 53
-
(1992)
Forest Prod J
, vol.42
, pp. 47-53
-
-
Cook, D.F.1
-
29
-
-
84986134895
-
The use of statistical process control in food packaging: Preliminary findings and future research agenda
-
N. Grigg, and L. Walls The use of statistical process control in food packaging: preliminary findings and future research agenda Br Food J 101 1999 763 784
-
(1999)
Br Food J
, vol.101
, pp. 763-784
-
-
Grigg, N.1
Walls, L.2
-
31
-
-
33644664215
-
Six Sigma and chemical process safety
-
M. Doble Six Sigma and chemical process safety Int J Six Sigma Compet Adv 1 2005 229 244
-
(2005)
Int J Six Sigma Compet Adv
, vol.1
, pp. 229-244
-
-
Doble, M.1
-
32
-
-
0037077422
-
Standards for Privacy of Individually Identifiable Health Information: Final rule
-
Standards for Privacy of Individually Identifiable Health Information: final rule Fed Regist 67 2002 53182 53273
-
(2002)
Fed Regist
, vol.67
, pp. 53182-53273
-
-
-
33
-
-
0032580320
-
Two-sided confidence intervals for the single proportion: Comparison of seven methods
-
R.G. Newcombe Two-sided confidence intervals for the single proportion: comparison of seven methods Stat Med 17 1998 857 872
-
(1998)
Stat Med
, vol.17
, pp. 857-872
-
-
Newcombe, R.G.1
-
35
-
-
0022681753
-
Modeling the detection rates of fires in nuclear plants. Development and application of a methodology for treating imprecise evidence
-
N. Siu, and G. Apostolakis Modeling the detection rates of fires in nuclear plants. Development and application of a methodology for treating imprecise evidence Risk Anal 6 1986 43 59
-
(1986)
Risk Anal
, vol.6
, pp. 43-59
-
-
Siu, N.1
Apostolakis, G.2
-
36
-
-
0001185873
-
Essay towards solving a problem in the doctrine of chances
-
T. Bayes Essay towards solving a problem in the doctrine of chances Philos Trans R Soc Lond 53 1763 370 418
-
(1763)
Philos Trans R Soc Lond
, vol.53
, pp. 370-418
-
-
Bayes, T.1
-
37
-
-
3242684955
-
Exploration of a Bayesian updating methodology to monitor the safety of interventional cardiovascular procedures
-
F.S. Resnic, K.H. Zou, D.V. Do, G. Apostolakis, and L. Ohno-Machado Exploration of a Bayesian updating methodology to monitor the safety of interventional cardiovascular procedures Med Decis Making 24 2004 399 407
-
(2004)
Med Decis Making
, vol.24
, pp. 399-407
-
-
Resnic, F.S.1
Zou, K.H.2
Do, D.V.3
Apostolakis, G.4
Ohno-Machado, L.5
-
38
-
-
0035902515
-
Simple bedside additive tool for prediction of in-hospital mortality after percutaneous coronary interventions
-
M. Moscucci, E. Kline-Rogers, and D. Share Simple bedside additive tool for prediction of in-hospital mortality after percutaneous coronary interventions Circulation 104 2001 263 268
-
(2001)
Circulation
, vol.104
, pp. 263-268
-
-
Moscucci, M.1
Kline-Rogers, E.2
Share, D.3
-
39
-
-
26044483543
-
Discrimination and calibration of mortality risk prediction models in interventional cardiology
-
M.E. Matheny, L. Ohno-Machado, and F.S. Resnic Discrimination and calibration of mortality risk prediction models in interventional cardiology J Biomed Inform 38 2005 367 375
-
(2005)
J Biomed Inform
, vol.38
, pp. 367-375
-
-
Matheny, M.E.1
Ohno-Machado, L.2
Resnic, F.S.3
|