An example of US food and drug administration device regulation: Medical devices indicated for use in acute ischemic stroke

Stroke

Volumn 38, Issue 6, 2007, Pages 1988-1992

  Peña, Carlos ^a,b   Li, Khan ^a   Felten, Richard ^a   Ogden, Neil ^a   Melkerson, Mark ^a  

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

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

Author keywords

Acute stroke; Stroke; Treatment

Indexed keywords

ALTEPLASE;

BRAIN BLOOD FLOW; BRAIN ISCHEMIA; DEVICE; DRUG APPROVAL; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; STROKE; THROMBECTOMY;

ACUTE DISEASE; ANIMALS; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; DEVICE APPROVAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34249781405     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/STROKEAHA.106.473918     Document Type: Review

References (13)

1. National Institute of Neurological Disorders and Stroke Web site. What you need to know about stroke. Available at: http://www.ninds.nih.gov/disorders/ stroke/stroke_needtoknow.htm. Accessed September 2, 2006.
2. Food and Drug Administration Web site. Overview of what we do. Available at: http://www.fda.gov/cdrh/overview2.html. Accessed September 2, 2006.
3. Food and Drug Administration Web site. Overview of regulations. Available at: http://www.fda.gov/cdrh/devadvice/overview.html. Accessed September 2, 2006.
4. Pena C, Bowsher K, Samuels-Reid J. FDA-approved neurologic devices intended for use in infants, children, and adolescents. Neurology. 2004;63:1163-1167.
5. Food and Drug Administration Web site. Overview. Available at: http://www.fda.gov/cdrh/devadvice/pma/. Accessed September 2, 2006.
6. Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke: The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999;282:2003-2011.
7. Smith WS, Sung G, Starkman S, Saver JL, Kidwell CS, Gobin YP, Lutsep HL, Nesbit GM, Grobelny T, Rymer MM, Silverman IE, Higashida RT, Budzik RF, Marks MP, MERCI Trial Investigators. Safety and efficacy of mechanical embolectomy in acute ischemic stroke: results of the MERCI trial. Stroke. 2005;36:1432-1438.
8. Hacke W, Kaste M, Fieschi C, Toni D, Lesaffre E, von Kummer R, Boysen G, Bluhmki E, Hoxter G, Mahagne MH. Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Stroke Study (ECASS). JAMA. 1995;274:1017-1025.
9. Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998;352:1245-1251.
10. Clark WM, Wissman S, Albers GW, Jhamandas JH, Madden KP, Hamilton S. Recombinant tissue-type plasminogen activator (alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS study: a randomized controlled trial. Alteplase thrombolysis for acute noninterventional therapy in ischemic stroke. JAMA. 1999;282:2019-2026.
11. Felten RP, Ogden NR, Pena C, Provost MC, Schlosser MJ, Witten CM. The food and drug administration medical device review process: clearance of a clot retriever for use in ischemic stroke. Stroke. 2005;34:404-406.
12. Becker KJ, Brott TG. Approval of the MERCI clot retriever: a critical view. Stroke. 2005;36:400-403.
13. Furlan A, Fisher M. Devices, drugs, and the food and drug administration: increasing implications for ischemic stroke. Stroke. 2005;36:398-399.