-
2
-
-
85011584503
-
-
US Food and Drug Administration. Published. Accessed June 29, 2016
-
US Food and Drug Administration. Premarket approval. http://www.fda.gov/Medicaldevices/Deviceregulationandguidance/Howtomarketyourdevice/Premarketsubmissions/Premarketapprovalpma/Default.Htm. Published 2016. Accessed June 29, 2016.
-
(2016)
Premarket Approval
-
-
-
5
-
-
84868313703
-
Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval
-
Chen CE, Dhruva SS, Redberg RF,. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. JAMA. 2012; 308: 1740-1742.
-
(2012)
JAMA
, vol.308
, pp. 1740-1742
-
-
Chen, C.E.1
Dhruva, S.S.2
Redberg, R.F.3
-
6
-
-
73949084847
-
Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices
-
Dhruva SS, Bero LA, Redberg RF,. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009; 302: 2679-2685.
-
(2009)
JAMA
, vol.302
, pp. 2679-2685
-
-
Dhruva, S.S.1
Bero, L.A.2
Redberg, R.F.3
-
7
-
-
84931260898
-
Pivotal clinical trials of novel ophthalmic drugs and medical devices: Retrospective observational study, 2002-2012
-
Hwang J, Hwang TJ, Ciolino JB,. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012. BMJ Open. 2015; 5: e007987.
-
(2015)
BMJ Open
, vol.5
, pp. e007987
-
-
Hwang, J.1
Hwang, T.J.2
Ciolino, J.B.3
-
8
-
-
84899845894
-
Postmarketing trials and pediatric device approvals
-
Hwang TJ, Kesselheim AS, Bourgeois FT,. Postmarketing trials and pediatric device approvals. Pediatrics. 2014; 133: e1197-e1202.
-
(2014)
Pediatrics
, vol.133
, pp. e1197-e1202
-
-
Hwang, T.J.1
Kesselheim, A.S.2
Bourgeois, F.T.3
-
10
-
-
84963930653
-
Physicians' knowledge about FDA approval standards and perceptions of the "breakthrough therapy" designation
-
Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM,. Physicians' knowledge about FDA approval standards and perceptions of the "breakthrough therapy" designation. JAMA. 2016; 315: 1516-1518.
-
(2016)
JAMA
, vol.315
, pp. 1516-1518
-
-
Kesselheim, A.S.1
Woloshin, S.2
Eddings, W.3
Franklin, J.M.4
Ross, K.M.5
Schwartz, L.M.6
-
11
-
-
84939155744
-
-
US Food and Drug Administration. Published. Accessed June 29, 2016
-
US Food and Drug Administration. Premarket approval (PMA) database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm. Published 2015. Accessed June 29, 2016.
-
(2015)
Premarket Approval (PMA) Database
-
-
-
12
-
-
84940999506
-
-
US Food and Drug Administration. Published. Accessed June 29, 2016
-
US Food and Drug Administration. Product code classification files. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm. Published 2014. Accessed June 29, 2016.
-
(2014)
Product Code Classification Files
-
-
-
13
-
-
70349914121
-
Using effectiveness and cost-effectiveness to make drug coverage decisions: A comparison of Britain, Australia, and Canada
-
Clement FM, Harris A, Li JJ, Yong K, Lee KM, Manns BJ,. Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA. 2009; 302: 1437-1443.
-
(2009)
JAMA
, vol.302
, pp. 1437-1443
-
-
Clement, F.M.1
Harris, A.2
Li, J.J.3
Yong, K.4
Lee, K.M.5
Manns, B.J.6
-
14
-
-
84892726671
-
Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012
-
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS,. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA. 2014; 311: 368-377.
-
(2014)
JAMA
, vol.311
, pp. 368-377
-
-
Downing, N.S.1
Aminawung, J.A.2
Shah, N.D.3
Krumholz, H.M.4
Ross, J.S.5
-
15
-
-
84941009742
-
-
US Food and Drug Administration. Published. Accessed June 29, 2016
-
US Food and Drug Administration. Post-approval studies database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma-pas.cfm. Published 2015. Accessed June 29, 2016.
-
(2015)
Post-approval Studies Database
-
-
-
16
-
-
84872082045
-
The 510(k) ancestry of a metal-on-metal hip implant
-
Ardaugh BM, Graves SE, Redberg RF,. The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med. 2013; 368: 97-100.
-
(2013)
N Engl J Med
, vol.368
, pp. 97-100
-
-
Ardaugh, B.M.1
Graves, S.E.2
Redberg, R.F.3
-
17
-
-
84893129008
-
Presumed safe no more: Lessons from the Wingspan saga on regulation of devices
-
Gartenberg AJ, Peleg A, Dhruva SS, Redberg RF,. Presumed safe no more: lessons from the Wingspan saga on regulation of devices. BMJ. 2014; 348: g93.
-
(2014)
BMJ
, vol.348
, pp. g93
-
-
Gartenberg, A.J.1
Peleg, A.2
Dhruva, S.S.3
Redberg, R.F.4
-
18
-
-
40449140715
-
Semper fidelis - Consumer protection for patients with implanted medical devices
-
Maisel WH,. Semper fidelis-consumer protection for patients with implanted medical devices. N Engl J Med. 2008; 358: 985-987.
-
(2008)
N Engl J Med
, vol.358
, pp. 985-987
-
-
Maisel, W.H.1
-
19
-
-
80052834654
-
Stenting versus aggressive medical therapy for intracranial arterial stenosis
-
Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011; 365: 993-1003.
-
(2011)
N Engl J Med
, vol.365
, pp. 993-1003
-
-
Chimowitz, M.I.1
Lynn, M.J.2
Derdeyn, C.P.3
-
20
-
-
85011593943
-
-
US Food and Drug Administration. Published. Accessed October 23, 2016
-
US Food and Drug Administration. Medical device recalls. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm. Published 2016. Accessed October 23, 2016.
-
(2016)
Medical Device Recalls
-
-
-
21
-
-
84963502461
-
Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 US Food and Drug Administration approvals
-
Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS,. Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 US Food and Drug Administration approvals. Trials. 2016; 17: 199.
-
(2016)
Trials
, vol.17
, pp. 199
-
-
Downing, N.S.1
Shah, N.D.2
Neiman, J.H.3
Aminawung, J.A.4
Krumholz, H.M.5
Ross, J.S.6
-
23
-
-
85011581868
-
-
US Food and Drug Administration. Published. Accessed June 29, 2016
-
US Food and Drug Administration. Approval order: inspire upper airway stimulation. http://www.accessdata.fda.gov/cdrh-docs/pdf13/P130008A.pdf. Published 2014. Accessed June 29, 2016.
-
(2014)
Approval Order: Inspire Upper Airway Stimulation
-
-
-
25
-
-
84939133213
-
Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011
-
Rathi VK, Krumholz HM, Masoudi FA, Ross JS,. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA. 2015; 314: 604-612.
-
(2015)
JAMA
, vol.314
, pp. 604-612
-
-
Rathi, V.K.1
Krumholz, H.M.2
Masoudi, F.A.3
Ross, J.S.4
-
26
-
-
85011618606
-
-
American Academy of Otolaryngology-Head and Neck Surgery. Published. Accessed June 29, 2016
-
American Academy of Otolaryngology-Head and Neck Surgery. Regent ENT clinical data registry. http://www.entnet.org/content/otoregistry. Published 2016. Accessed June 29, 2016.
-
(2016)
Regent ENT Clinical Data Registry
-
-
|