- ►annals.org [PDF] WH Maisel - Annals of internal medicine, 2004 - Am Coll Physicians Patient care for the practicing physician increasingly relies on medical
devices. The US Food and Drug Administration is re- sponsible for the safety and
effectiveness of medical devices in the United States. In addition to ... Cited by 35 - Related articles - All 9 versions
L Kessler, K Richter - The American journal of managed care, 1998 - ncbi.nlm.nih.gov We reviewed the Food and Drug Administration's regulatory process for medical
devices and described the issues that arise in assessing device safety and
effectiveness during the postmarket period. The Center for Devices and ... Cited by 12 - Related articles - All 2 versions
RR Munsey - Food & Drug LJ, 1995 - heinonlinebackup.com 164 Food and Drug Law Journal 50th regulations applicable to devices. As had
been the case with drugs, the FDA was left only with "after-the-fact" regulation
of medical devices. Its only remedy was to con- vince the Department of ... Cited by 21 - Related articles - All 3 versions
LH Monsein - Radiology, 1997 - cat.inist.fr Primer on medical device regulation. Part I. History and background. LH MONSEIN
Radiology 205:11, 1-9, Radiological Society of North America, 1997. ... Cited by 14 - Related articles - BL Direct - All 4 versions
GG White, MD Weick-Brady, TP Gross - Clinical Toxicology, 1998 - informahealthcare.com An understanding of the routes by which medical devices come to be marketed, and
the limitations of what is known about a device before it is marketed, offers
valuable insight into why it is so important that health professionals ... Cited by 11 - Related articles - BL Direct - All 6 versions
WF Pritchard Jr, RF Carey - Radiology, 1997 - radiology.rsna.org The recent decision by the US Food and Drug Administration (FDA) to ap- prove
one ultrasound imaging system for use in making breast biopsy deci- sions
prompted considerable interest in the radiology community about the ... Cited by 13 - Related articles - View as HTML - BL Direct - All 6 versions
DW Feigal, SN Gardner, M McClellan - The New England Journal of Medicine, 2003 - nejm.highwire.org Renal imaging is recommended for children after a first documented urinary tract
infection. In this pro- spective study, 309 children between the ages of one
month and two years underwent renal imaging stud- ies ... Cited by 34 - Related articles - BL Direct - All 4 versions
WH Maisel - JAMA, 2005 - Am Med Assoc This past spring, Joshua Oukrop, a 21-year old Minnesota college student with
familial hypertrophic cardiomyopathy, died of cardiac arrest when his
implantable cardioverter-defibrillator (ICD) short-circuited and failed to ... Cited by 48 - Related articles - BL Direct - All 8 versions
- ►nih.gov MD Feldman, AJ Petersen, LS Karliner, JA … - Journal of General Internal Medicine, 2008 - Springer INTRODUCTION: The global medical technology indus- try brings thousands of
devices to market every year. However, significant gaps persist in the
scientific liter- ature, in the medical device approval process, and in the ... Cited by 9 - Related articles - BL Direct - All 6 versions
WH Maisel, WG Stevenson, LM Epstein - Pacing and Clinical Electrophysiology, 2002 - interscience.wiley.com MAISEL, WH, et al.: Changing Trends in Pacemaker and Implantable Cardioverter
Defibrillator Generator Advisories. Pacemaker and implantable cardioverter
defibrillator (ICD) generator recalls and safety alerts (advisories) occur ... Cited by 22 - Related articles - BL Direct - All 8 versions
